ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

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: NCT01270828
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : January 13, 2016
Last Update Posted : January 13, 2016
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 Post Herpetic Neuralgia
Interventions Drug: Pregabalin
Drug: placebo
Enrollment 806
Recruitment Details A total of 129 centers in 17 countries screened subjects for the study, including 68 in the US, 6 in Bulgaria, 6 in Poland, 6 in Russia, 6 in the Ukraine, 5 in India, 5 in South Africa, 5 in Sweden, 4 in Slovakia, 3 in Colombia, 3 in Croatia, 3 in Germany, 2 in Denmark, 2 in Hong Kong, 2 in Serbia, 2 in Taiwan, and 1 in the Czech Republic.
Pre-assignment Details The study consisted of 4 phases: Baseline (1 week [wk]): to determine study entry criteria; Single Blind (SB) (6 wks): to determine optimized dose; Double Blind (DB) (13 wks): responders with at least 50% improvement in pain at SB were considered and randomized to pregabalin or matching placebo; and DB taper phase (1 wk).
Arm/Group Title Pregabalin Controlled Release (CR) DB Placebo DB Pregabalin CR SB
Hide Arm/Group Description Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR. Participants received matching placebo The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
Period Title: Pregabalin CR SB
Started 0 0 806
Completed 0 0 660
Not Completed 0 0 146
Reason Not Completed
Reason Unspecified             0             0             8
Enrolled but not treated             0             0             5
Related adverse event             0             0             46
Lack of Efficacy             0             0             32
Withdrawal by Subject             0             0             29
Lost to Follow-up             0             0             10
Unrelated AE             0             0             8
Protocol Violation             0             0             8
Period Title: Double Blind Phase
Started 208 205 0
Completed 182 160 0
Not Completed 26 45 0
Reason Not Completed
Death             0             1             0
Protocol Violation             0             1             0
Protocol and GCP non-compliance             4             3             0
Reason Unspecified             7             4             0
Withdrawal by Subject             6             15             0
Lost to Follow-up             1             2             0
Lack of Efficacy             2             11             0
Adverse event not related to study drug             1             1             0
Adverse event related to study drug             5             7             0
Arm/Group Title Pregabalin CR DB Placebo DB Total
Hide Arm/Group Description Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR. Participants received matching placebo Total of all reporting groups
Overall Number of Baseline Participants 208 205 413
Hide Baseline Analysis Population Description
Baseline analysis population description consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase (full analysis set).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 208 participants 205 participants 413 participants
<18 years 0 0 0
18-44 years 26 24 50
45-64 years 86 78 164
≥65 years 96 103 199
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 205 participants 413 participants
Female
134
  64.4%
122
  59.5%
256
  62.0%
Male
74
  35.6%
83
  40.5%
157
  38.0%
1.Primary Outcome
Title Number of Participants With Loss of Therapeutic Response.
Hide Description Loss of Therapeutic Response (LTR) is defined as <30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of <30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.
Time Frame 13 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) was the primary efficacy analysis set and consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 208 205
Measure Type: Number
Unit of Measure: Participants
29 63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments Kaplan-Meier method was used for the analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results
Hide Description

A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as:

  1. At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score
  2. A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR.
Time Frame 13 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 208 205
Measure Type: Number
Unit of Measure: Participants
49 87
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments Kaplan-Meier method was used for the analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With 30% Reduction in the Mean Pain Score.
Hide Description The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint.
Time Frame 13 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 206 204
Measure Type: Number
Unit of Measure: Percentage of participants
95.6 83.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments Chi-square test was used for analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With 50% Reduction in the Mean Pain Score.
Hide Description The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint.
Time Frame 13 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 206 204
Measure Type: Number
Unit of Measure: Percentage of participants
88.3 68.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments Chi-square test was used for analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Endpoint in Weekly Mean Pain Score.
Hide Description The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain
Time Frame SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 206 205
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
SB Baseline to Week 19 -4.89  (0.12) -3.95  (0.12)
DB Baseline to Week 19 -0.04  (0.11) 0.87  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-1.26 to -0.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-1.21 to -0.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in the Weekly NRS-Pain (1-Week Recall).
Hide Description The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants were asked to rate their pain over the past week.
Time Frame SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 203 195
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
SB Baseline to Week 19 -5.0  (0.13) -3.9  (0.14)
DB Baseline to Week 19 -0.1  (0.13) 0.9  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.47 to -0.75
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.34 to -0.65
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).
Hide Description The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 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 assessing sleep over the past week. 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 SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 203 195
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Sleep Problems Index I-SB BL to wk 19(N=202,195) -19.9  (1.09) -16.7  (1.13)
Sleep Problems Index I-DB BL to wk 19(N=202,195) 1.2  (1.05) 4.4  (1.09)
SleepProblems Index II-SB BL to wk 19(N=202,195) -21.2  (1.07) -17.4  (1.11)
SleepProblems Index II-DB BL to wk 19(N=202,194) 0.2  (1.01) 4.3  (1.05)
Sleep Disturbance-SB BL to wk 19 -28.3  (1.42) -21.1  (1.48)
Sleep Disturbance-DB BL to wk 19 -1.1  (1.31) 7.6  (1.36)
Snoring-SB BL to wk 19(N=202,194) -3.3  (1.57) -4.7  (1.64)
Snoring-DB BL to wk 19(N=201,194) -0.6  (1.41) 0.8  (1.46)
Awaken short of breath/headache-SB BL to wk 19 -11.9  (1.21) -10.4  (1.26)
Awaken short of breath/headache-DB BL to wk 19 -1.2  (1.23) -0.2  (1.27)
Sleep adequacy-SB BL to wk 19 19.9  (1.83) 17.5  (1.90)
Sleep adequacy-DB BL to wk 19(N=202,195) -3.3  (1.82) -6.0  (1.89)
Somnolence-SB BL to wk 19(N=202,195) -12.0  (1.19) -12.0  (1.23)
Somnolence-DB BL to wk 19(N=203,194) -0.7  (1.15) -0.9  (1.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Sleep Problem Index I-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0324
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-6.1 to -0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Sleep Problem Index I-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0223
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.3
Confidence Interval (2-Sided) 95%
-6.1 to -0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments

This ANCOVA model analysis is for Sleep Problem Index II-SB Baseline to Week 19.

Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0098
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-6.6 to -0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments

This ANCOVA model analysis is for Sleep Problem Index II-DB Baseline to Week 19.

Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.0
Confidence Interval (2-Sided) 95%
-6.7 to -1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Sleep Disturbance-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.3
Confidence Interval (2-Sided) 95%
-11.1 to -3.5
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Sleep Disturbance-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.7
Confidence Interval (2-Sided) 95%
-12.2 to -5.2
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Snoring-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5264
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-2.8 to 5.6
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Snoring-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4520
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-5.2 to 2.3
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments

This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-SB Baseline to Week 19.

Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3714
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-4.7 to 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments

This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-DB Baseline to Week 19.

Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5639
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-4.2 to 2.3
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Sleep adequacy-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3223
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-2.4 to 7.3
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Sleep adequacy-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2742
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-2.2 to 7.6
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Somnolence-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9816
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.2 to 3.1
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Somnolence-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9282
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-2.9 to 3.2
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in the MOS-SS-Quantity of Sleep.
Hide Description

The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 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 assessing sleep over the past week.

The item "Quantity of sleep" of MOS-SS is presented here.

Time Frame SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 203 192
Least Squares Mean (Standard Error)
Unit of Measure: Hours
Quantity of sleep-SB BL to wk 19(N=203,192) 0.9  (0.09) 0.7  (0.10)
Quantity of sleep-DB BL to wk 19(N=202,192) -0.1  (0.08) -0.4  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1635
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.1 to 0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0363
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval 95%
0.0 to 0.5
Estimation Comments [Not Specified]
9.Secondary Outcome
Title The MOS-SS-Optimal Sleep.
Hide Description

The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 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 assessing sleep over the past week.

The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The "percentage of participants with optimal sleep" is presented here.

Time Frame Week 6 and Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 208 205
Measure Type: Number
Unit of Measure: Percentage of participants
Week 6 (N=208,205) 58.7 62.4
Week 19 (N=204,197) 54.9 54.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This analysis is for Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.432
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This analysis is for Week 19
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.987
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score
Hide Description The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse.
Time Frame Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 203 195
Measure Type: Number
Unit of Measure: Percentage of participants
Very much improved 31.5 23.1
Much improved 36.9 30.3
Minimally improved 16.7 19.0
No change 10.3 12.8
Minimally worse 2.5 7.2
Much worse 1.5 7.2
Very much worse 0.5 0.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This analysis is for the original score. Proportional odds Logistic regression with a term for treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.85
Confidence Interval (2-Sided) 95%
1.30 to 2.65
Estimation Comments

Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.

Odds ratio > 1 is in favor of Pregabalin DB.

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This analysis is for the categorized score. Proportional odds Logistic regression with a term for treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.32
Confidence Interval (2-Sided) 95%
1.41 to 3.81
Estimation Comments

Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.

Odds ratio > 1 is in favor of Pregabalin DB.

11.Secondary Outcome
Title Change in the Short Form 36 Health Survey (SF-36)
Hide Description The SF 36 is a self administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) where, higher scores indicate a better health related quality of life.
Time Frame Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 203 195
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Physical Component-SB BL to wk 19(N=202,195) 7.5  (0.54) 5.6  (0.56)
Physical Component-DB BL to wk 19(N=202,195) 0.1  (0.51) -2.3  (0.53)
Mental Component-SB BL to wk 19(N=202,195) 6.4  (0.62) 5.5  (0.64)
Mental Component-DB BL to wk 19(N=202,195) -1.1  (0.62) -2.2  (0.64)
Physical functioning-SB BL to wk 19 11.7  (1.44) 8.9  (1.49)
Physical functioning-DB BL to wk 19 -1.4  (1.25) -4.9  (1.29)
Role-Physical-SB BL to wk 19 18.9  (1.62) 13.9  (1.67)
Role-Physical-DB BL to wk 19 -2.4  (1.54) -7.7  (1.60)
Bodily pain-SB BL to wk 19 31.0  (1.51) 23.6  (1.56)
Bodily pain-DB BL to wk 19 1.4  (1.38) -6.2  (1.43)
General Health Perception-SB BL to wk19(N=202,195) 11.3  (1.05) 8.2  (1.08)
General Health Perception-DB BL to wk19(N=202,195) 1.4  (0.96) -4.0  (1.00)
Vitality-SB BL to wk 19(N=202,195) 13.7  (1.25) 10.7  (1.30)
Vitality-DB BL to wk 19(N=202,195) -3.5  (1.21) -6.5  (1.25)
Social Functioning-SB BL to wk 19 18.5  (1.35) 15.7  (1.39)
Social Functioning-DB BL to wk 19 -2.1  (1.28) -4.3  (1.32)
Role-Emotional-SB BL to wk 19 15.0  (1.43) 11.6  (1.47)
Role-Emotional-DB BL to wk 19 -1.4  (1.42) -5.4  (1.47)
Mental Health-SB BL to wk 19(N=202,195) 11.1  (1.05) 9.5  (1.08)
Mental Health-DB BL to wk 19(N=202,195) -1.3  (1.04) -3.7  (1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Bodily pain-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.4
Confidence Interval (2-Sided) 95%
3.4 to 11.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Bodily pain-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.7
Confidence Interval (2-Sided) 95%
4.0 to 11.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments

This ANCOVA model analysis is for General Health Perceptions-SB Baseline to Week 19.

Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0275
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
0.4 to 6.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments

This ANCOVA model analysis is for General Health Perceptions-DB Baseline to Week 19.

Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
2.8 to 8.0
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Vitality-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0735
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-0.3 to 6.4
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Vitality-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0684
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-0.2 to 6.2
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Social Functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1197
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-0.7 to 6.4
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Social Functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2210
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-1.3 to 5.5
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Role-Emotional-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0847
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-0.5 to 7.1
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Role-Emotional-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0365
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
0.3 to 7.8
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2749
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-1.2 to 4.3
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0806
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-0.3 to 5.2
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Physical component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0082
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
0.5 to 3.4
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Physical component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
1.0 to 3.7
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Mental component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2097
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-0.8 to 2.5
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Mental component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1669
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-0.5 to 2.8
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Physical functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1466
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-1.0 to 6.7
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Physical functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0439
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
0.1 to 6.7
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Role Physical-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0250
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
0.6 to 9.3
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Role Physical-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0107
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
1.3 to 9.5
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in Mean Daily Sleep Interference Scores
Hide Description The pain related sleep interference item rating scale is scored on an 11 point numeric rating scale (NRS Sleep). It is self administered by the subject in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain)). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.
Time Frame Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 206 204
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
SB Baseline to Week 19 (N=205,203) -4.5  (0.11) -3.5  (0.11)
DB Baseline to Week 19 (N=206,204) -0.2  (0.10) 0.7  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for SB Baseline to Week 19.Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.23 to -0.64
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.12 to -0.58
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change in Hospital Anxiety and Depression Scales (HADS)
Hide Description The HADS is a self administered questionnaire that was designed to screen for the presence of a mood disorder in medically ill patients. To distinguish psychiatric presentations from physical illness, the items focus on subjective disturbance of mood rather than physical signs. The HADS contains 14 items rated on 4 point Likert type scales. Two subscales assess depression and anxiety. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression). Separate scores are calculated for each subscale ranging from 0 to 21. Higher scores denote greater severity of depression or anxiety
Time Frame Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 203 195
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
HADS-Anxiety-SB Baseline to Week 19 -1.8  (0.21) -1.1  (0.21)
HADS-Anxiety-DB Baseline to Week 19 0.1  (0.19) 0.9  (0.20)
HADS-Depression-SB Baseline to Week 19 -1.8  (0.20) -1.2  (0.21)
HADS-Depression-DB Baseline to Week 19 0.2  (0.19) 0.8  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for HADS-Anxiety-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0154
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.2 to -0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for HADS-Anxiety-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.3 to -0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for HADS-Depression-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0166
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.2 to -0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for HADS-Depression-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0217
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.1 to -0.1
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change in the Brief Pain Inventory (BPI-sf)
Hide Description The BPI sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI sf consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11 point scale from 0 (no pain) to 10 (worst pain possible). Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions on an 11 point scale from 0 (Does not interfere) to 10 (Completely interferes).
Time Frame Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 203 195
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Pain Severity Index-SB Baseline to Week 19 -18.0  (0.47) -13.8  (0.49)
Pain Severity Index-DB Baseline to Week 19 -0.7  (0.43) 3.1  (0.44)
Pain Interference Index-SB Baseline to Week 19 -21.9  (0.71) -17.2  (0.74)
Pain Interference Index-DB Baseline to Week 19 -0.2  (0.67) 4.0  (0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Pain Severity Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-5.5 to -3.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This ANCOVA model analysis is for Pain Severity Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-5.0 to -2.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments

This ANCOVA model analysis is for Pain Interference Index-SB Baseline to Week 19.

Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.6
Confidence Interval (2-Sided) 95%
-6.5 to -2.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments

This ANCOVA model analysis is for Pain Interference Index-DB Baseline to Week 19.

Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-6.0 to -2.4
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)
Hide Description The BSW is administered by the study physician or designated site personnel and consists of three single item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.
Time Frame Week 19
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 201 193
Measure Type: Number
Unit of Measure: Percentage of participants
Benefit from treatment 98.5 93.3
Satisfaction with treatment 96.0 90.7
Willingness to continue treatment 87.6 81.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This analysis is for 'Benefit from treatment'. Proportional odds logistic regression was used with a term for treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0161
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.77
Confidence Interval (2-Sided) 95%
1.34 to 17.00
Estimation Comments Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio > 1 was in favor of pregabalin CR.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This analysis is for 'Satisfaction with treatment'. Proportional odds logistic regression was used with a term for treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0378
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.48
Confidence Interval (2-Sided) 95%
1.05 to 5.85
Estimation Comments Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio > 1 was in favor of pregabalin CR.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin CR DB, Placebo DB
Comments This analysis is for 'Willingness to continue treatment'. Proportional odds logistic regression was used with a term for treatment in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0901
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
0.93 to 2.81
Estimation Comments Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio > 1 was in favor of pregabalin CR.
16.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or Results in congenital anomaly/birth defect. The study physician used the adjective "severe" to those AEs that interfere significantly with participant's usual function.
Time Frame Baseline to Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

The SB Analysis Set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication; The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Both SBAS and FAS were included in this analysis.

Arm/Group Title Pregabalin CR DB Placebo DB Pregabalin CR SB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
Overall Number of Participants Analyzed 208 205 801
Measure Type: Number
Unit of Measure: Participants
Participants with AEs 80 63 441
Participants with Serious AEs 7 3 17
Participants with Severe AEs 9 3 35
17.Secondary Outcome
Title Percentage of Participants With Suicidal Behaviour/Ideation
Hide Description Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.
Time Frame Baseline, Weeks 6, 11, 15, 19 and 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.
Arm/Group Title Pregabalin CR DB Placebo DB
Hide Arm/Group Description:
Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Participants received matching placebo
Overall Number of Participants Analyzed 208 205
Measure Type: Number
Unit of Measure: Percentage of participants
SB BL(N=208,205) 0 0.5
Week 6 (N=208,205) 0 0
Week 11 (N=194,178) 0 0
Week 15 (N=183,167) 0 0
Week 19 (N=204,197) 0 0
Week 20 (N=199,194) 0 0
Time Frame Baseline to Week 20
Adverse Event Reporting Description The SB analysis set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication; The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Both SBAS and FAS were included in this analysis
 
Arm/Group Title Pregabalin CR DB Placebo DB Pregabalin CR SB
Hide Arm/Group Description Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR. Participants received matching placebo The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
All-Cause Mortality
Pregabalin CR DB Placebo DB Pregabalin CR SB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin CR DB Placebo DB Pregabalin CR SB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/208 (3.37%)   3/205 (1.46%)   17/801 (2.12%) 
Blood and lymphatic system disorders       
Anaemia of chronic disease * 1  1/208 (0.48%)  0/205 (0.00%)  0/801 (0.00%) 
Thrombocytopenia * 1  0/208 (0.00%)  1/205 (0.49%)  0/801 (0.00%) 
Cardiac disorders       
Acute myocardial infarction * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Cardiac failure * 1  1/208 (0.48%)  0/205 (0.00%)  0/801 (0.00%) 
Gastrointestinal disorders       
Gastrooesophageal reflux disease * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
General disorders       
Chest pain * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Infections and infestations       
Acute sinusitis * 1  1/208 (0.48%)  0/205 (0.00%)  0/801 (0.00%) 
Bronchopneumonia * 1  0/208 (0.00%)  1/205 (0.49%)  0/801 (0.00%) 
Perirectal abscess * 1  1/208 (0.48%)  0/205 (0.00%)  0/801 (0.00%) 
Septic shock * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Pneumonia * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Urinary tract infection * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Injury, poisoning and procedural complications       
Femoral neck fracture * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Investigations       
Liver function test abnormal * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
White blood cell count increased * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Hyponatraemia * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  1/208 (0.48%)  0/205 (0.00%)  0/801 (0.00%) 
Nervous system disorders       
Cerebrovascular accident * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Cerebrovascular disorder * 1  0/208 (0.00%)  1/205 (0.49%)  0/801 (0.00%) 
Sciatica * 1  1/208 (0.48%)  0/205 (0.00%)  0/801 (0.00%) 
Syncope * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Transient ischaemic attack * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Vertebrobasilar insufficiency * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Renal and urinary disorders       
Haematuria * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Renal mass * 1  1/208 (0.48%)  0/205 (0.00%)  0/801 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Chronic obstructive pulmonary disease * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
Social circumstances       
Sexual abuse * 1  0/208 (0.00%)  0/205 (0.00%)  1/801 (0.12%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin CR DB Placebo DB Pregabalin CR SB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/208 (3.37%)   1/205 (0.49%)   202/801 (25.22%) 
Nervous system disorders       
Dizziness * 1  7/208 (3.37%)  1/205 (0.49%)  137/801 (17.10%) 
Somnolence * 1  1/208 (0.48%)  0/205 (0.00%)  91/801 (11.36%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
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: NCT01270828     History of Changes
Other Study ID Numbers: A0081224
2009-016766-86 ( EudraCT Number )
First Submitted: January 4, 2011
First Posted: January 5, 2011
Results First Submitted: October 1, 2015
Results First Posted: January 13, 2016
Last Update Posted: January 13, 2016