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Trial record 73 of 424 for:    Pregabalin

Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01332149
Recruitment Status : Completed
First Posted : April 8, 2011
Results First Posted : June 19, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetic Neuropathy, Painful
Interventions Drug: Pregabalin
Drug: Placebo matched with pregabalin
Enrollment 626
Recruitment Details All participants were Chinese. 626 participants were randomized initially, as originally stated on clinicaltrials.gov. However, 3 participants discontinued right after randomization without any treatment information. As such, the actual number of participants randomized and assigned to treatment was 623 as stated in the “Started” Row below.
Pre-assignment Details  
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Period Title: Overall Study
Started 314 [1] 309 [1]
Treated 313 307
Completed 284 271
Not Completed 30 38
Reason Not Completed
Adverse Event             11             9
Other unspecified             5             7
Protocol Violation             1             3
Withdrawal by Subject             4             5
Lost to Follow-up             1             1
Insufficient clinical response             4             7
Did not meet entrance criteria             3             4
Randomized but not treated             1             2
[1]
Assigned to study treatment.
Arm/Group Title Pregabalin Placebo Total
Hide Arm/Group Description Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. Total of all reporting groups
Overall Number of Baseline Participants 313 307 620
Hide Baseline Analysis Population Description
The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 313 participants 307 participants 620 participants
18-44 years 25 15 40
45-64 years 172 178 350
More than or equal to (>=) 65 years 116 114 230
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 313 participants 307 participants 620 participants
Female
159
  50.8%
168
  54.7%
327
  52.7%
Male
154
  49.2%
139
  45.3%
293
  47.3%
1.Primary Outcome
Title Baseline Mean Pain Score
Hide Description The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 313 307
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.65  (1.117) 6.67  (1.150)
2.Primary Outcome
Title Change From Baseline in Mean Pain Score at Endpoint
Hide Description The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
Time Frame Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 312 307
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.14  (0.115) -1.86  (0.117)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0559
Comments Primary analysis was two-sided and performed at the 0.05 significance level. No multiple comparisons adjustment was made.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.58 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.148
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9
Hide Description The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.
Time Frame Baseline and weekly from Weeks 1 to 9
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 313 307
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 1 change from baseline (N=312, 307) -0.60  (0.091) -0.36  (0.092)
Week 2 change from baseline (N=304, 295) -0.97  (0.092) -0.71  (0.093)
Week 3 change from baseline (N=298, 291) -1.25  (0.092) -1.01  (0.093)
Week 4 change from baseline (N=297, 289) -1.47  (0.092) -1.21  (0.093)
Week 5 change from baseline (N=296, 287) -1.61  (0.092) -1.39  (0.093)
Week 6 change from baseline (N=293, 278) -1.84  (0.092) -1.59  (0.094)
Week 7 change from baseline (N=290, 275) -2.04  (0.092) -1.77  (0.094)
Week 8 change from baseline (N=290, 275) -2.18  (0.092) -1.88  (0.094)
Week 9 change from baseline (N=287, 273) -2.32  (0.092) -2.07  (0.094)
Overall change from baseline -1.59  (0.082) -1.33  (0.083)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0527
Comments All analyses were two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.47 to 0.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.120
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0279
Comments All analyses were two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.50 to -0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.121
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0508
Comments All analyses were two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.48 to 0.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.121
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0349
Comments All analyses were two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.49 to -0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.121
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0672
Comments All analyses were two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.46 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.122
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0469
Comments All analyses were two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.48 to -0.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.122
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0280
Comments All analyses were two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.51 to -0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.122
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0140
Comments All analyses were two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-0.54 to -0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.122
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0375
Comments All analyses were two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.49 to -0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.122
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0164
Comments All analyses were two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.46 to -0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.105
Estimation Comments Overall change was estimated from the mixed effect model treatment main effect.
4.Secondary Outcome
Title Baseline 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]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 313 307
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.25  (2.236) 5.12  (2.278)
5.Secondary Outcome
Title Change From Baseline in Mean Sleep Interference Score at Endpoint
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]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 9 (Day 63) dose.
Time Frame Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 311 307
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.52  (0.110) -1.30  (0.112)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1340
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.49 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.143
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9
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]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.
Time Frame Baseline and weekly from Weeks 1 to 9
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 313 307
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 1 change from baseline (N=311, 307) -0.38  (0.096) -0.26  (0.098)
Week 2 change from baseline (N=303, 295) -0.66  (0.097) -0.51  (0.098)
Week 3 change from baseline (N=297, 291) -0.88  (0.097) -0.72  (0.099)
Week 4 change from baseline (N=296, 289) -1.06  (0.097) -0.86  (0.099)
Week 5 change from baseline (N=295, 287) -1.14  (0.097) -0.98  (0.099)
Week 6 change from baseline (N=292, 278) -1.32  (0.098) -1.07  (0.099)
Week 7 change from baseline (N=289, 275) -1.43  (0.098) -1.25  (0.099)
Week 8 change from baseline (N=289, 275) -1.59  (0.098) -1.36  (0.099)
Week 9 change from baseline (N=286, 273) -1.67  (0.098) -1.49  (0.100)
Overall change from baseline -1.13  (0.085) -0.94  (0.087)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3438
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.37 to 0.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.127
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2482
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.40 to 0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.128
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2249
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.41 to 0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.129
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1094
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.46 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.129
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2095
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.41 to 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.129
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0531
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.50 to 0.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.129
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1628
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.44 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.130
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0770
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.48 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.130
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1651
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.43 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.130
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1006
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.40 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.110
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of 30 Percent (%) Responders at Endpoint
Hide Description The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 63/Week 9) (Study Endpoint) compared to baseline.
Time Frame End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 312 307
Measure Type: Number
Unit of Measure: percentage of participants
50.3 44.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1309
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.93 to 1.74
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9
Hide Description SF-MPQ was assessed according to the participant’s answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.
Time Frame Baseline; Weeks 1, 5, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point. No inferential analyses were performed.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 313 307
Mean (Standard Deviation)
Unit of Measure: units on a scale
Sensory score, Baseline (N=313, 306) 7.90  (5.101) 8.11  (5.098)
Sensory score, Week 1 change (N=311, 304) -1.50  (3.422) -1.34  (3.134)
Sensory score, Week 5 change (N=297, 288) -2.89  (4.244) -2.47  (3.925)
Sensory score, Week 9 change (N=288, 274) -3.87  (4.432) -3.37  (4.348)
Affective score, Baseline (N=313, 307) 1.25  (1.809) 1.20  (1.817)
Affective score, Week 1 change (N=311, 304) -0.41  (1.569) -0.37  (1.410)
Affective score, Week 5 change (N=297, 289) -0.72  (1.724) -0.62  (1.652)
Affective score, Week 9 change (N=287, 274) -0.75  (1.744) -0.62  (1.792)
Total score, Baseline (N=313, 307) 9.15  (6.118) 9.28  (6.445)
Total score, Week 1 change (N=311, 305) -1.92  (4.260) -1.70  (3.908)
Total score, Week 5 change (N=297, 289) -3.61  (5.084) -3.07  (4.893)
Total score, Week 9 change (N=288, 274) -4.62  (5.272) -4.00  (5.512)
9.Secondary Outcome
Title Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale
Hide Description The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 313 307
Mean (Standard Deviation)
Unit of Measure: units on a scale
VAS 69.08  (11.474) 69.06  (11.811)
PPI 2.28  (0.784) 2.27  (0.830)
10.Secondary Outcome
Title Change From Baseline in Pain VAS From the SF-MPQ at Endpoint
Hide Description The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 310 304
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-25.07  (1.260) -21.82  (1.279)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0463
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.25
Confidence Interval (2-Sided) 95%
-6.45 to -0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.628
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in PPI Scale From the SF-MPQ at Endpoint
Hide Description The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 309 305
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.80  (0.047) -0.73  (0.048)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2748
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.19 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.061
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores
Hide Description The MOS-Sleep Scale was a participant-rated instrument which assesses sleep quantity and quality with 12 items (7 subscale scores: sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep; and a 9-item overall sleep problems index). Subscale scores total range: 0-100 (except sleep quantity [range 0-24 hours], optimal sleep [yes:1, no:0]). Higher scores=poorer sleep outcomes (except sleep quantity, adequacy, and optimal sleep).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. N=number of evaluable participants for each category
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 313 307
Mean (Standard Deviation)
Unit of Measure: units on a scale
Sleep disturbance score (N=313, 307) 36.29  (24.768) 35.13  (26.915)
Snoring score (N=312, 307) 35.13  (36.670) 37.59  (37.163)
Awaken short of breath score (N=313, 307) 11.50  (21.557) 10.75  (21.883)
Quantity of sleep score (N=311, 304) 6.07  (2.882) 5.98  (1.451)
Sleep adequacy score (N=313, 307) 57.32  (31.518) 60.88  (30.274)
Somnolence score (N=312, 307) 33.87  (20.459) 36.03  (21.491)
Sleep problems index score (N=312, 307) 32.19  (19.806) 31.21  (20.388)
13.Secondary Outcome
Title Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint
Hide Description The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 297 286
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.11  (1.222) -7.98  (1.244)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4758
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.13
Confidence Interval (2-Sided) 95%
-4.22 to 1.97
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.577
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint
Hide Description The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 295 285
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.78  (1.716) -0.53  (1.743)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1363
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.31
Confidence Interval (2-Sided) 95%
-1.05 to 7.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.220
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint
Hide Description The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 295 286
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.10  (1.061) -2.31  (1.078)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8808
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-2.49 to 2.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.371
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint
Hide Description The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 295 280
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.33  (0.085) 0.14  (0.087)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0887
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-0.03 to 0.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.110
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants Who Had Optimal Sleep at Endpoint
Hide Description The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.
Time Frame Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 297 282
Measure Type: Number
Unit of Measure: percentage of participants
43.8 45.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7929
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.72 to 1.53
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint
Hide Description The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 297 285
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
8.87  (1.532) 7.82  (1.552)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5960
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
-2.83 to 4.92
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.973
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint
Hide Description The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 295 285
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.22  (1.187) -0.88  (1.208)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8216
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-3.36 to 2.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.536
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint
Hide Description The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 294 284
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.71  (0.914) -5.88  (0.927)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4829
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-3.14 to 1.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.177
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Clinical Global Impression of Change (CGIC) at Endpoint
Hide Description The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician’s perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
Time Frame Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 299 290
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.58  (0.057) 2.73  (0.058)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analysis performed using a general linear model with treatment and center as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0431
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.29 to -0.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.073
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Patient Global Impression of Change (PGIC) Score at Endpoint
Hide Description The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant’s perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
Time Frame Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 297 290
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.60  (0.057) 2.74  (0.058)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analysis performed using a general linear model with treatment and center as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0602
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.28 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.074
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Baseline Hospital Anxiety and Depression Scale (HADS) Scores
Hide Description The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 313 307
Mean (Standard Deviation)
Unit of Measure: units on a scale
Anxiety total score 3.76  (3.800) 3.67  (3.645)
Depression total score 4.45  (4.081) 4.35  (3.798)
24.Secondary Outcome
Title Change From Baseline in HADS Anxiety Total Score at Endpoint
Hide Description The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 296 286
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.48  (0.161) -0.31  (0.163)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4172
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.57 to 0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.207
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in HADS Depression Total Score at Endpoint
Hide Description The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Time Frame Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Overall Number of Participants Analyzed 297 286
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.57  (0.169) -0.38  (0.172)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3724
Comments Analysis was two-sided and performed at the 0.05 significance level.
Method ANCOVA
Comments The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.62 to 0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.218
Estimation Comments [Not Specified]
Time Frame From Baseline till Week 10 (Day 70) and/or Early Termination.
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
 
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
All-Cause Mortality
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   7/314 (2.23%)   5/308 (1.62%) 
Cardiac disorders     
Cardiac failure * 1  1/314 (0.32%)  0/308 (0.00%) 
Eye disorders     
Cataract * 1  1/314 (0.32%)  0/308 (0.00%) 
Infections and infestations     
Gastroenteritis * 1  1/314 (0.32%)  0/308 (0.00%) 
Infection * 1  0/314 (0.00%)  1/308 (0.32%) 
Musculoskeletal and connective tissue disorders     
Spinal osteoarthritis * 1  0/314 (0.00%)  1/308 (0.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Glioma * 1  0/314 (0.00%)  1/308 (0.32%) 
Nervous system disorders     
Basal ganglia haemorrhage * 1  1/314 (0.32%)  0/308 (0.00%) 
Cerebral infarction * 1  1/314 (0.32%)  2/308 (0.65%) 
Diabetic neuropathy * 1  1/314 (0.32%)  0/308 (0.00%) 
Hypoglycaemic coma * 1  0/314 (0.00%)  1/308 (0.32%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease * 1  1/314 (0.32%)  0/308 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   77/314 (24.52%)   55/308 (17.86%) 
Eye disorders     
Vision blurred * 1  4/314 (1.27%)  0/308 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  6/314 (1.91%)  7/308 (2.27%) 
Nausea * 1  5/314 (1.59%)  0/308 (0.00%) 
General disorders     
Oedema peripheral * 1  10/314 (3.18%)  1/308 (0.32%) 
Hepatobiliary disorders     
Hepatic function abnormal * 1  4/314 (1.27%)  0/308 (0.00%) 
Infections and infestations     
Nasopharyngitis * 1  4/314 (1.27%)  6/308 (1.95%) 
Upper respiratory tract infection * 1  7/314 (2.23%)  6/308 (1.95%) 
Urinary tract infection * 1  7/314 (2.23%)  12/308 (3.90%) 
Metabolism and nutrition disorders     
Hyperuricaemia * 1  2/314 (0.64%)  5/308 (1.62%) 
Nervous system disorders     
Dizziness * 1  30/314 (9.55%)  12/308 (3.90%) 
Headache * 1  4/314 (1.27%)  6/308 (1.95%) 
Somnolence * 1  18/314 (5.73%)  6/308 (1.95%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01332149     History of Changes
Other Study ID Numbers: A0081265
First Submitted: April 7, 2011
First Posted: April 8, 2011
Results First Submitted: March 23, 2015
Results First Posted: June 19, 2015
Last Update Posted: June 19, 2015