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Trial record 1 of 1 for:    NCT00407745
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A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT00407745
Recruitment Status : Completed
First Posted : December 5, 2006
Results First Posted : December 8, 2011
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Neuralgia
Spinal Cord Injuries
Interventions Drug: placebo
Drug: pregabalin
Enrollment 220
Recruitment Details  
Pre-assignment Details 1 participant was randomized after the first dose of study drug was taken; the participant was randomized to placebo, but the actual drug taken was pregabalin. This partcipant was included in the placebo group for all baseline characteristics and efficacy outcome measures; and in the pregabalin group for overall study and adverse events reporting.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study. Placebo matching study treatment.
Period Title: Overall Study
Started 112 108
Treated 112 107
Completed 93 91
Not Completed 19 17
Reason Not Completed
Lack of Efficacy             1             2
Withdrawal by Subject             3             3
Protocol Violation             5             3
Adverse Event             8             8
Other             2             0
Randomized, unknown if treated             0             1
Arm/Group Title Pregabalin Placebo Total
Hide Arm/Group Description Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study. Placebo matching study treatment. Total of all reporting groups
Overall Number of Baseline Participants 111 108 219
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 108 participants 219 participants
46.1  (12.7) 45.6  (13.8) 45.9  (13.3)
[1]
Measure Description: 1 participant was randomized to placebo, but the actual drug taken was pregabalin. This subject was included in the placebo group for all baseline measures.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 111 participants 108 participants 219 participants
Between 18 and 44 years 52 53 105
Between 45 and 64 years 50 45 95
>= 65 years 9 10 19
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 108 participants 219 participants
Female
27
  24.3%
16
  14.8%
43
  19.6%
Male
84
  75.7%
92
  85.2%
176
  80.4%
1.Primary Outcome
Title Duration Adjusted Average Change (DAAC) of Mean Pain Score
Hide Description DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT: all randomized participants who received at least one dose of study medication except the 8 participants who were randomized before protocol amendment 2.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
-1.66  (0.157) -1.07  (0.149)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Null hypothesis - the mean DAAC for the pregabalin group is equal to the mean DAAC for the placebo group; Alternative hypothesis - the mean DAAC for the placebo group differs from the mean DAAC for the pregabalin group.

ANCOVA model included baseline severity of pain and Baseline Pain Catastrophizing Scale (PCS) Total Score as covariates and pooled center and treatment as fixed (class) cofactors.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments Significance was declared if the 2-tailed test for the difference between treatment groups was significant at the 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-0.98 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.198
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Weekly Mean Pain Score
Hide Description Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; modified baseline observation carried forward (mBOCF) imputation: mBOCF mean pain score was defined as the baseline mean pain score for participants who discontinued double-blind treatment due to adverse event or who had no postbaseline observations and as the last observation carried forward (LOCF) mean pain score for all other participants.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline 6.5  (1.45) 6.5  (1.41)
Change from baseline at endpoint -1.9  (1.91) -1.2  (1.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0066
Comments Serial gate-keeping multiple testing procedure was used. If primary comparison for DAAC was significant, then variables were assessed in a hierarchical manner. Significance was declared if unadjusted p-value was significant at 0.05 level (<=0.05).
Method ANCOVA
Comments ANCOVA model included baseline severity (pain) and baseline PCS as covariates and effects for treatment and pooled center as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.20 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.255
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline
Hide Description Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF: LOCF Endpoint corresponded to the last 7 days of diary data up to and including Week 16 and applied if the Week 16 assessment was missing; (N) = number of participants that can be analyzed for the endpoint.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 105
Measure Type: Number
Unit of Measure: participants
48 33
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0390
Comments Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.
Method Regression, Logistic
Comments Logistic regression model used terms for baseline pain score and baseline PCS total score as covariate, and pooled center and treatment as cofactor.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.85
Confidence Interval (2-Sided) 95%
1.032 to 3.328
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)
Hide Description The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (N) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 100 99
Measure Type: Number
Unit of Measure: participants
1-Very much improved 7 2
2-Much improved 33 25
3-Minimally improved 38 24
4-No change 19 40
5-Minimally worse 2 5
6-Much worse 0 3
7-Very much worse 1 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - The raw mean score for the pregabain group was equal to the raw mean score for the placebo group; Alternative hypothesis - The raw mean score for the pregabain group was not equal to the raw mean score for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.
Method Cochran-Mantel-Haenszel
Comments Modified ridit transformation with the Cochran-Mantel- Haenszel test was used with adjusting for pooled center.
5.Secondary Outcome
Title Change From Baseline in Weekly Mean Sleep Interference Score
Hide Description Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 105, 105) 4.9  (2.48) 5.2  (2.24)
Change from baseline at endpoint (n = 105, 104) -2.0  (2.35) -1.0  (1.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.
Method ANCOVA
Comments ANCOVA model included baseline sleep interference score as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.08
Confidence Interval (2-Sided) 95%
-1.60 to -0.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.265
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Weekly Mean Pain Score by Week
Hide Description Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time Frame Baseline, Week 1 through16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: defined as all randomized participants who took at least one dose of study medication. (This population included the 8 participants who were randomized before the protocol amendment 2). (n) = number of participants with data for analysis.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 111 108
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 111, 108) 6.44  (1.44) 6.51  (1.40)
Change at Week 1 (n = 111, 107) -0.85  (1.04) -0.38  (0.89)
Change at Week 2 (n = 110, 105) -1.26  (1.21) -0.62  (1.30)
Change at Week 3 (n = 107, 105) -1.35  (1.35) -0.86  (1.35)
Change at Week 4 (n = 107, 103) -1.64  (1.61) -1.03  (1.53)
Change at Week 5 (n = 105, 101) -1.87  (1.73) -1.07  (1.50)
Change at Week 6 (n = 105, 99) -1.89  (1.90) -1.22  (1.72)
Change at Week 7 (n = 103, 98) -2.02  (1.86) -1.34  (1.75)
Change at Week 8 (n = 101, 97) -1.96  (1.82) -1.32  (1.82)
Change at Week 9 (n = 98, 97) -1.99  (1.81) -1.37  (1.75)
Change at Week 10 (n = 97, 91) -2.03  (1.75) -1.32  (1.81)
Change at Week 11 (n = 96, 90) -2.04  (1.82) -1.43  (1.84)
Change at Week 12 (n = 96, 91) -1.90  (1.83) -1.44  (1.93)
Change at Week 13 (n = 93, 91) -2.02  (1.76) -1.39  (1.92)
Change at Week 14 (n = 93, 92) -2.00  (1.76) -1.34  (1.89)
Change at Week 15 (n = 93, 92) -2.09  (1.80) -1.41  (1.85)
Change at Week 16 (n = 89, 90) -2.17  (1.78) -1.36  (1.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 1

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0295
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.94 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 2

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-1.11 to -0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 3

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0185
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-0.98 to -0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 4

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0040
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.10 to -0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 5

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.81
Confidence Interval (2-Sided) 95%
-1.26 to -0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 6

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-1.17 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 7

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-1.14 to -0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 8

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.11 to -0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 9

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-1.09 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 10

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-1.14 to -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 11

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0076
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.08 to -0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 12

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0328
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.95 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 13

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0150
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-1.02 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 14

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.11 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 15

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0030
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-1.15 to -0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 16

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.22 to -0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline
Hide Description Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (N) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 105
Measure Type: Number
Unit of Measure: participants
31 16
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0256
Comments Significance was declared if p-value <=0.05
Method Regression, Logistic
Comments Logistic regression used terms for treatment, baseline pain score as covariate, baseline PCS total score, and pooled center as cofactor.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.24
Confidence Interval (2-Sided) 95%
1.103 to 4.546
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score
Hide Description The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline 4.7  (2.18) 4.9  (2.21)
Change from baseline at endpoint (n = 100, 99) -1.6  (2.19) -1.1  (2.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0438
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline mBPI-10 Total Score as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.08 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.269
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia
Hide Description Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 83, 82) 2.9  (3.16) 2.6  (2.95)
Change from baseline at endpoint (n = 79, 75) -1.0  (2.69) -0.3  (2.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

At/above level: within 2 dermatomes above or below the neurological level of injury (NLI).

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7103
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-1.06 to 0.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.448
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Below level: more than 2 dermatomes below the NLI.

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0747
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.28 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.340
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia
Hide Description Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 83, 82) 2.7  (2.81) 2.3  (2.84)
Change from baseline at endpoint (n = 79, 75) -0.6  (2.35) -0.3  (2.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

At/Above level

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5689
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.97 to 0.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.379
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Below level

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4764
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.87 to 0.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.322
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia
Hide Description Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n=83,82) 3.9  (3.41) 3.4  (3.19)
Change from baseline at endpoint (n=79,75) -1.0  (2.36) -0.4  (2.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

At/Above level

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3362
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-1.40 to 0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.474
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Below level

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3113
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.96 to 0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.321
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli
Hide Description Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 83, 82) 4.1  (3.54) 3.9  (3.48)
Change from baseline at endpoint (n = 79, 75) -0.5  (2.21) -0.8  (2.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

At/Above level

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2721
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-1.67 to 0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.539
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Below level

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4906
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-0.43 to 0.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.337
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia
Hide Description Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 83, 82) 2.5  (2.97) 2.7  (3.13)
Change from baseline at endpoint (n = 79, 72) -0.1  (2.12) 0.4  (2.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

At/Above level

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3123
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-1.42 to 0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.472
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Below level

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1360
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.28 to 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.368
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales
Hide Description Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 83, 82) 2.8  (3.18) 2.8  (3.25)
Change from baseline at endpoint (n = 79, 72) -0.1  (2.60) 0.4  (2.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

At/Above level

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4257
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-1.53 to 0.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.549
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Below level

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2005
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-1.34 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.412
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score
Hide Description Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 104, 106) 0.4  (0.20) 0.4  (0.22)
Change from baseline at endpoint (n = 99, 99) -0.1  (0.21) -0.1  (0.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1377
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - 12 Items Total Intensity Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.09 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.025
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain
Hide Description Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF;(n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline 0.5  (0.32) 0.5  (0.30)
Change from baseline at endpoint (n = 100, 99) -0.1  (0.34) -0.1  (0.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3312
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Burning Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.11 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.038
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain
Hide Description Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline 0.4  (0.31) 0.4  (0.31)
Change from baseline at endpoint (n = 100, 99) -0.1  (0.28) -0.0  (0.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0440
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Pressing Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.13 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.033
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Hide Description Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline 0.4  (0.29) 0.3  (0.30)
Change from baseline at endpoint (n = 100, 99) -0.1  (0.31) -0.1  (0.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1370
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Paroxysmal Pain as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.12 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.033
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Hide Description Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline 0.4  (0.29) 0.4  (0.29)
Change from baseline at endpoint (n = 100, 99) -0.1  (0.24) -0.1  (0.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8911
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Evoked pain as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.06 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.028
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia
Hide Description Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 104, 106) 0.5  (0.28) 0.5  (0.28)
Change from baseline at endpoint (n = 99, 99) -0.1  (0.29) -0.1  (0.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3731
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Paresthesia/Dysesthesia as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.10 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.034
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score
Hide Description Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
1- Burning pain (n = 100, 99) -1.39  (3.420) -1.00  (2.825)
2- Squeezing pain (n = 100, 99) -1.04  (3.181) -0.41  (3.110)
3- Pain like pressure (n = 100, 99) -0.73  (3.429) -0.20  (3.326)
5- Electric shocks (n = 100, 99) -1.77  (3.426) -0.68  (3.664)
6- Stabbing pain (n = 100, 99) -1.13  (3.541) -0.52  (2.804)
8- By light touching (n = 100, 99) -0.78  (3.080) -0.94  (2.683)
9- By pressure (n = 100, 99) -1.22  (2.784) -1.10  (2.675)
10- By something cold (n = 100, 99) -0.89  (3.372) -0.52  (2.459)
11- Pins and needles (n = 99, 99) -1.01  (3.125) -0.62  (3.269)
12- Tingling (n = 99, 99) -0.99  (3.559) -0.83  (3.034)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Item 1 - Burning pain

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3312
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-1.13 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.383
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Item 2 - Squeezing pain

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0976
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.37 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.377
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Item 3 - Pain like pressure

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0538
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.54 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.393
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Item 5 - Electric shocks

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3239
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-1.15 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.389
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Item 6 - Stabbing pain

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1912
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-1.23 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.376
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Item 8 - By light touching

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6720
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.55 to 0.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.353
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Item 9 - By pressure

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7821
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.74 to 0.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.330
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Item 10 - By something cold

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6851
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.84 to 0.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.352
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Item 11 - Pins and needles

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3610
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-1.12 to 0.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.387
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Item 12 - Tingling

Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4915
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-1.07 to 0.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.402
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)
Hide Description NPSI - Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
MITT; LOCF; (N) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 100 97
Measure Type: Number
Unit of Measure: participants
39 28
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0536
Comments p-values are adjusted for baseline score. Significance was declared if p-value <=0.05.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
23.Secondary Outcome
Title Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)
Hide Description NPSI - Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
MITT; LOCF; (N) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 100 99
Measure Type: Number
Unit of Measure: participants
48 38
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3107
Comments p-values are adjusted for baseline score. Significance was declared if p-value <=0.05.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index
Hide Description Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 105, 103) 45.7  (18.02) 45.9  (19.00)
Change from baseline at endpoint (n = 100, 95) -10.8  (16.70) -5.8  (16.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0262
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline MOS 9-item Sleep Problems Index as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.89
Confidence Interval (2-Sided) 95%
-9.19 to -0.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.182
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance
Hide Description Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 105, 104) 51.9  (25.88) 51.2  (26.68)
Change from baseline at endpoint (n = 100, 97) -17.3  (25.25) -8.0  (21.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline MOS - Sleep disturbance as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -8.67
Confidence Interval (2-Sided) 95%
-14.55 to -2.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.985
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy
Hide Description Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 105, 104) 42.3  (25.92) 43.8  (26.92)
Change from baseline at endpoint (n = 100, 97) 11.6  (27.26) 5.7  (28.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0998
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline MOS - Sleep Adequacy as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.78
Confidence Interval (2-Sided) 95%
-1.11 to 12.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.492
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring
Hide Description Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 105, 104) 31.2  (34.07) 35.6  (35.47)
Change from baseline at endpoint (n = 100, 97) 2.2  (25.88) -4.7  (27.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1048
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline MOS - Snoring as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.70
Confidence Interval (2-Sided) 95%
-1.20 to 12.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.501
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache
Hide Description Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 105, 105) 15.0  (23.00) 12.8  (23.23)
Change from baseline at endpoint (n = 100, 98) -6.2  (22.33) -0.2  (22.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0347
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included baseline MOS - Awaken Short of Breath or with headache as covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.14
Confidence Interval (2-Sided) 95%
-9.91 to -0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.417
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity
Hide Description Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 104,105) 5.9  (1.45) 6.2  (1.64)
Change from baseline at endpoint (n = 100, 98) 0.6  (1.42) 0.2  (1.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0436
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline MOS - Sleep Quantity as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.01 to 0.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.189
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence
Hide Description Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 105, 105) 36.3  (19.81) 39.7  (23.43)
Change from baseline at endpoint (n = 100, 97) -0.8  (20.64) -4.9  (22.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2761
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline MOS - Somnolence as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.02
Confidence Interval (2-Sided) 95%
-2.44 to 8.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.770
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)
Hide Description Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (N) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 100 99
Measure Type: Number
Unit of Measure: participants
49 30
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - The rate of subjects with optimal sleep for the pregabain group was equal to the rate of subjects with optimal sleep for the placebo group; Alternative hypothesis - The rate of subjects with optimal sleep for the pregabain group was not equal to the rate of subjects with optimal sleep for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments Significance was declared if p-value <=0.05
Method Regression, Logistic
Comments Logistic Regression Model included Pooled Center and Treatment as the categorical factors, and Optimal Sleep Score at Baseline as the covariate.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.81
Confidence Interval (2-Sided) 95%
1.443 to 5.491
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety
Hide Description HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline 6.7  (4.41) 6.9  (4.12)
Change from baseline at endpoint (n = 100, 99) -1.4  (3.21) -0.8  (3.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1164
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline HADS - Anxiety as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-1.54 to 0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.433
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression
Hide Description HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 105 106
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline 5.2  (3.96) 6.3  (3.99)
Change from baseline at endpoint (n = 100, 99) -1.0  (3.44) -0.5  (3.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0279
Comments Significance was declared if p-value <=0.05
Method ANCOVA
Comments ANCOVA model included terms of baseline HADS - Depression as a covariate and pooled center and treatment as fixed (class) cofactors.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-1.87 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.447
Estimation Comments [Not Specified]
34.Other Pre-specified Outcome
Title Change From Baseline in Weekly Mean Sleep Interference Score by Week
Hide Description Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).
Time Frame Baseline, Week 1 through 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; (n) = number of participants with data available for analysis
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
Placebo matching study treatment.
Overall Number of Participants Analyzed 111 108
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n = 111, 107) 4.86  (2.46) 5.18  (2.23)
Change at Week 1 (n = 111, 106) -0.96  (1.45) -0.26  (0.85)
Change at Week 2 (n = 110, 104) -1.29  (1.63) -0.49  (1.17)
Change at Week 3 (n = 107, 104) -1.36  (1.68) -0.61  (1.27)
Change at Week 4 (n = 107, 102) -1.59  (1.85) -0.90  (1.45)
Change at Week 5 (n = 105, 100) -1.81  (2.05) -0.91  (1.38)
Change at Week 6 (n = 105, 98) -1.86  (2.14) -0.99  (1.48)
Change at Week 7 (n = 103, 97) -1.98  (2.19) -1.10  (1.50)
Change at Week 8 (n = 101, 96) -1.97  (2.18) -1.11  (1.59)
Change at Week 9 (n = 98, 96) -2.03  (2.13) -1.11  (1.72)
Change at Week 10 (n = 97, 90) -2.18  (2.06) -1.12  (1.74)
Change at Week 11 (n = 96, 89) -2.08  (2.15) -1.20  (1.85)
Change at Week 12 (n = 96, 90) -2.07  (2.21) -1.20  (1.75)
Change at Week 13 (n = 93, 90) -2.08  (2.21) -1.19  (1.82)
Change at Week 14 (n = 93, 91) -2.09  (2.13) -1.18  (1.83)
Change at Week 15 (n = 93, 91) -2.15  (2.10) -1.11  (1.83)
Change at Week 16 (n = 89, 89) -2.25  (2.24) -1.17  (1.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 1.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.79
Confidence Interval (2-Sided) 95%
-1.23 to -0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week2

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.31 to -0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 3.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-1.24 to -0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 4.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.20 to -0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 5.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-1.38 to -0.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 6.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.93
Confidence Interval (2-Sided) 95%
-1.37 to -0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 7.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-1.35 to -0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 8.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-1.35 to -0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 9.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-1.39 to -0.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 10.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.08
Confidence Interval (2-Sided) 95%
-1.53 to -0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 11.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-1.39 to -0.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 12.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.37 to -0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 13.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.38 to -0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 14.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-1.41 to -0.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 15.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.08
Confidence Interval (2-Sided) 95%
-1.53 to -0.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments

Week 16.

A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.

Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric.

Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Significance was declared if p-value <=0.05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-1.51 to -0.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
Time Frame Baseline up to and including 28 calendar days after the last administration of the study treatment
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study. Placebo matching study treatment.
All-Cause Mortality
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/112 (8.04%)   10/107 (9.35%) 
Cardiac disorders     
Bradycardia * 1  1/112 (0.89%)  0/107 (0.00%) 
Prinzmetal angina * 1  1/112 (0.89%)  0/107 (0.00%) 
Ear and labyrinth disorders     
Ear haemorrhage * 1  0/112 (0.00%)  1/107 (0.93%) 
Hepatobiliary disorders     
Cholecystitis * 1  0/112 (0.00%)  1/107 (0.93%) 
Cholelithiasis * 1  1/112 (0.89%)  0/107 (0.00%) 
Infections and infestations     
Osteomyelitis chronic * 1  0/112 (0.00%)  1/107 (0.93%) 
Pneumonia * 1  3/112 (2.68%)  0/107 (0.00%) 
Pyelonephritis acute * 1  0/112 (0.00%)  1/107 (0.93%) 
Urinary tract infection * 1  0/112 (0.00%)  1/107 (0.93%) 
Injury, poisoning and procedural complications     
Fall * 1  0/112 (0.00%)  1/107 (0.93%) 
Head injury * 1  0/112 (0.00%)  1/107 (0.93%) 
Ulna fracture * 1  1/112 (0.89%)  0/107 (0.00%) 
Investigations     
Blood amylase increased * 1  1/112 (0.89%)  0/107 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  1/112 (0.89%)  0/107 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/112 (0.00%)  1/107 (0.93%) 
Muscle spasms * 1  1/112 (0.89%)  0/107 (0.00%) 
Pain in extremity * 1  1/112 (0.89%)  0/107 (0.00%) 
Periarthritis * 1  0/112 (0.00%)  1/107 (0.93%) 
Nervous system disorders     
Dystonia * 1  0/112 (0.00%)  1/107 (0.93%) 
Renal and urinary disorders     
Calculus urinary * 1  0/112 (0.00%)  1/107 (0.93%) 
Dysuria * 1