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Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

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: NCT01701362
Recruitment Status : Completed
First Posted : October 5, 2012
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
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 Neuropathic Pain
Interventions Drug: pregabalin
Drug: placebo
Enrollment 542
Recruitment Details

A total of 187 centers participated in the study in 14 countries.

During screening, with the exception of daily pain score data that was collected to determine participants eligibility, no participants were treated with active drug and no efficacy data were collected. Only safety and no efficacy data was collected during the taper period.

Pre-assignment Details Participants had clinic visits at screening, randomization, and during the treatment period, and a phone contact for follow-up after the last taper dose. All the eligible participants were randomly assigned (1:1) to 15 weeks of treatment with Pregabalin or Placebo.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase. Participants randomized to receive placebo
Period Title: Overall Study
Started 275 267
TREATED 274 265
Completed 233 211
Not Completed 42 56
Reason Not Completed
Adverse events not related to study drug             1             6
Adverse events related to study drug             12             10
Protocol Violation             5             3
No longer willing to participate             8             14
Lost to Follow-up             6             9
Insufficient clinical response             6             6
Death             0             1
Randomized but not treated             1             2
Reasons other than those mentioned above             3             5
Arm/Group Title Pregabalin Placebo Total
Hide Arm/Group Description Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase. Participants randomized to receive placebo Total of all reporting groups
Overall Number of Baseline Participants 274 265 539
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 274 participants 265 participants 539 participants
52.8  (12.9) 53.4  (12.7) 53.1  (12.8)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 274 participants 265 participants 539 participants
18 - 44 years 59 61 120
45 - 64 years 163 154 317
>=65 years 52 50 102
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 265 participants 539 participants
Female
132
  48.2%
134
  50.6%
266
  49.4%
Male
142
  51.8%
131
  49.4%
273
  50.6%
1.Primary Outcome
Title Baseline Mean Pain Score
Hide Description This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Subjects describe 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
Intent to Treat (ITT) population: all randomized participants who took at least one dose of study drug
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 274 265
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.41  (1.30) 6.54  (1.30)
2.Primary Outcome
Title Change From Baseline to Week 15 in Weekly Mean Pain Score
Hide Description This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Time Frame up to Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who took at least one dose of study drug
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 274 265
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.12  (0.15) -1.90  (0.16)
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 0.1823
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Mixed Model Repeated Measures = MMRM
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value -0.22
Confidence Interval 95%
-0.54 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments MMRM analysis includes fixed categorical effects of treatment, country, trauma type, visit week, treatment-by-visit interaction, and fixed continuous effect of baseline value. Missing mean pain scores imputed by multiple imputation method
3.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at Week 15
Hide Description A self administered instrument that measures changes in participants’ overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who took at least one dose of study drug
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 258 246
Measure Type: Number
Unit of Measure: Participants
Very much improved 52 41
Much improved 105 79
Minimally improved 61 62
No change 34 51
Minimally worse 5 9
Much worse 0 4
Very much worse 1 0
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 0.0012
Comments The p-value is derived from CMH test, stratified for pooled center and trauma type and excludes missing values.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)
Hide Description

This is an 11-point NRS ranging from 0 (“pain does not interfere with sleep”) to 10 ("pain completely interferes with sleep" [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.

Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings.

"Overall" is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks.

Time Frame up to Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who took at least one dose of study drug
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 274 265
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (raw scores) (N = 274, 265) 4.97  (2.30) 4.99  (2.27)
Week 1 (N = 260, 258) -0.66  (1.10) -0.28  (0.91)
Week 2 (N = 254, 244) -1.15  (1.51) -0.81  (1.27)
Week 3 (N = 252, 245) -1.55  (1.73) -1.14  (1.45)
Week 4 (N = 245, 229) -1.73  (1.80) -1.30  (1.63)
Week 5 (N = 241, 226) -1.87  (1.87) -1.40  (1.68)
Week 6 (N = 244, 227) -1.94  (1.95) -1.46  (1.79)
Week 7 (N = 240, 216) -2.01  (1.99) -1.50  (1.78)
Week 8 (N = 236, 212) -2.05  (2.00) -1.52  (1.76)
Week 9 (N = 232, 214) -2.09  (1.99) -1.55  (1.86)
Week 10 (N = 229, 212) -2.04  (2.11) -1.55  (1.83)
Week 11 (N = 230, 211) -2.09  (2.05) -1.64  (1.79)
Week 12 (N = 227, 209) -2.17  (2.06) -1.68  (1.89)
Week 13 (N = 225, 204) -2.19  (2.06) -1.70  (1.90)
Week 14 (N = 222, 208) -2.19  (2.16) -1.79  (1.89)
Week 15 (N = 196, 186) -2.13  (2.17) -1.83  (1.87)
Overall (N = 269, 262) -1.83  (1.93) -1.37  (1.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0119
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.35
Confidence Interval 95%
-0.62 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0135
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.34
Confidence Interval 95%
-0.62 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0028
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.42
Confidence Interval 95%
-0.69 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.44
Confidence Interval 95%
-0.72 to -0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.48
Confidence Interval 95%
-0.75 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.48
Confidence Interval 95%
-0.76 to -0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.48
Confidence Interval 95%
-0.75 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.52
Confidence Interval 95%
-0.79 to -0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.54
Confidence Interval 95%
-0.82 to -0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.49
Confidence Interval 95%
-0.77 to -0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.48
Confidence Interval 95%
-0.76 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.54
Confidence Interval 95%
-0.82 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.56
Confidence Interval 95%
-0.84 to -0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.50
Confidence Interval 95%
-0.78 to -0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.43
Confidence Interval 95%
-0.71 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Overall
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Model Repeated Measures Analysis
Comments Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.47
Confidence Interval 95%
-0.71 to -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])
Hide Description A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who took at least one dose of study drug
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 258 246
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.40  (0.13) -1.95  (0.13)
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 0.0050
Comments [Not Specified]
Method ANCOVA
Comments This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value -0.46
Confidence Interval 95%
-0.77 to -0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Pain Interference Index (BPI-sf)
Hide Description

BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation.

It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes).

The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores.

Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who took at least one dose of study drug
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 274 265
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.72  (0.13) -1.33  (0.13)
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 0.0168
Comments [Not Specified]
Method ANCOVA
Comments This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval 95%
-0.70 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores
Hide Description A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant’s overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who took at least one dose of study drug
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 274 265
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Mobility -0.10  (0.03) -0.09  (0.03)
Self-care -0.08  (0.02) -0.06  (0.02)
Usual activities -0.12  (0.03) -0.13  (0.04)
Pain/Discomfort -0.35  (0.03) -0.29  (0.04)
Anxiety/Depression 0.01  (0.03) -0.02  (0.03)
Dolan 1997 Index Score 0.12  (0.01) 0.11  (0.01)
Dolan 2001 Index Score -0.13  (0.02) -0.12  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments This statistical analysis is for mobility
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6841
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value -0.01
Confidence Interval 95%
-0.09 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.037
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments This statistical analysis is for self-care
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6564
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value -0.01
Confidence Interval 95%
-0.07 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.029
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments This statistical analysis is for usual activities
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8590
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value 0.01
Confidence Interval 95%
-0.08 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.043
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments This statistical analysis is for pain/discomfort
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1628
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value -0.06
Confidence Interval 95%
-0.14 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.043
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments This statistical analysis is for anxiety/depression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4654
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter leaset squares mean difference
Estimated Value 0.03
Confidence Interval 95%
-0.05 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.037
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments This statistical analysis is for Dolan 1997 Index score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value 0.01
Confidence Interval 95%
-0.02 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.017
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments This statistical analysis is for Dolan 2001 Index Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5493
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter leaset squares mean difference
Estimated Value -0.02
Confidence Interval 95%
-0.07 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.026
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
Hide Description

MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.

Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.

Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.

Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.

Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who took at least one dose of study drug.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 274 265
Median (Full Range)
Unit of Measure: Units on a scale
Sleep Disturbance Score (N = 274, 265)
42.50
(0 to 100)
43.75
(0 to 100)
Sleep Adequancy Score (N = 274, 265)
40.0
(0 to 100)
40.0
(0 to 100)
Snoring Score (N = 272, 263)
20.0
(0 to 100)
20.0
(0 to 100)
Awaken Short of Breath Score (N = 274, 265)
0.0
(0.0 to 100)
0.0
(0.0 to 100)
Quantity of Sleep Score (hours) (N = 273, 265)
6.0
(2.0 to 10.0)
6.0
(2.0 to 10.0)
Somnolence Score (N = 274, 265)
26.67
(0.0 to 100)
26.67
(0.0 to 100)
Sleep Problem Index (9) Score (N = 274, 265)
40.56
(0.0 to 88.3)
41.11
(0.0 to 88.9)
Optimal Sleep Score (N = 273, 265)
0.0
(0.0 to 1.0)
0.0
(0.0 to 1.0)
9.Secondary Outcome
Title Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
Hide Description

MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.

Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.

Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.

Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.

Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.

Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who took at least one dose of study drug.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 274 265
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Sleep Disturbance Score (N = 257, 245)
-14.71
(-17.57 to -11.85)
-11.24
(-14.16 to -8.33)
Sleep Adequancy Score (N=257, 245)
10.13
(6.49 to 13.76)
8.16
(4.43 to 11.89)
Snoring Score (N = 257, 245)
-2.22
(-5.46 to 1.03)
-3.27
(-6.59 to 0.04)
Awaken Short of Breath Score (N = 257, 245)
-3.61
(-6.30 to -0.92)
-3.03
(-5.78 to -0.27)
Quantity of Sleep Score (hours) (N = 257, 245)
0.42
(0.19 to 0.66)
0.26
(0.03 to 0.50)
Somnolence Score (N = 257, 245)
-1.61
(-3.99 to 0.77)
-3.74
(-6.17 to -1.31)
Sleep Problem Index (9) Score (N = 257, 245)
-9.86
(-12.17 to -7.56)
-8.19
(-10.55 to -5.83)
Optimal Sleep Score (N = 256, 245)
0.11
(0.05 to 0.18)
0.04
(-0.03 to 0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis for Sleep Disturbance Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0545
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value 3.5
Confidence Interval 95%
-0.07 to 7.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.80
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis for Sleep Adequancy Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3913
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -2.0
Confidence Interval 95%
-6.47 to 2.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.29
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis for Snoring Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6059
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -1.1
Confidence Interval 95%
-5.06 to 2.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.04
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis for Awaken Short of Breath Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7317
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value 0.6
Confidence Interval 95%
-2.76 to 3.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.70
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis for Quantity of Sleep Score (hours)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2663
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.2
Confidence Interval 95%
-0.45 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Statistical analysis for Somnolence Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1562
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -2.1
Confidence Interval 95%
-5.08 to 0.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.50
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis for Sleep Problem Index (9) Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2490
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter least square mean difference
Estimated Value 1.7
Confidence Interval 95%
-1.18 to 4.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.45
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis for Optimal Sleep Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0609
Comments [Not Specified]
Method ANCOVA
Comments This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.
Method of Estimation Estimation Parameter leaet squares mean difference
Estimated Value -0.1
Confidence Interval 95%
-0.15 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants in MOS-SS With Optimal Sleep Status.
Hide Description MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized subjects who took at least one dose of study drug
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 274 265
Measure Type: Number
Unit of Measure: Percentage of participants
Any Improvements 21.2 18.5
No Change 66.1 60.8
Any Worsening 6.2 13.2
Not applicable 6.6 7.5
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 0.7165
Comments p-values based on CMH test stratified by pooled center and trauma type, patients with unknown status at baseline or endpoint will not be included in the calculation of p-values.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.
Hide Description Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who took at least one dose of study drug
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 274 265
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 (N = 260, 258) 11.92 5.04
Week 2 (N = 254, 244) 27.17 20.08
Week 3 (N = 252, 245) 38.89 30.20
Week 4 (N = 246, 229) 41.87 34.50
Week 5 (N = 241, 226) 45.64 38.05
Week 6 (N = 244, 227) 48.77 41.41
Week 7 (N = 240, 216) 49.58 43.06
Week 8 (N = 236, 213) 50.42 46.48
Week 9 (N = 232, 214) 50.86 47.66
Week 10 (N = 229, 212) 52.84 47.17
Week 11 (N = 231, 211) 52.38 51.18
Week 12 (N = 227, 209) 54.63 52.63
Week 13 (N = 226, 204) 57.08 54.41
Week 14 (N = 223, 208) 57.40 54.33
Week 15 (N = 196, 187) 57.65 58.29
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0028
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.20
Confidence Interval 95%
1.50 to 6.86
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0360
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.66
Confidence Interval 95%
1.03 to 2.68
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0235
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.62
Confidence Interval 95%
1.07 to 2.45
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0619
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.48
Confidence Interval 95%
0.98 to 2.24
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0677
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.46
Confidence Interval 95%
0.97 to 2.20
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0707
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval 95%
0.97 to 2.16
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1313
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval 95%
0.91 to 2.06
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3072
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.24
Confidence Interval 95%
0.82 to 1.86
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3947
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval 95%
0.79 to 1.80
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1462
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval 95%
0.90 to 2.05
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6854
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval 95%
0.72 to 1.64
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5025
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval 95%
0.76 to 1.74
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4908
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval 95%
0.76 to 1.76
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4245
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval 95%
0.78 to 1.80
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8464
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval 95%
0.61 to 1.49
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%
Hide Description Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who took at least one dose of study drug
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Participants randomized to receive placebo
Overall Number of Participants Analyzed 274 265
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 (N = 260, 258) 4.62 2.33
Week 2 (N = 254, 244) 11.42 6.97
Week 3 (N = 252, 245) 22.62 13.47
Week 4 (N = 246, 229) 25.20 17.90
Week 5 (N = 241, 226) 28.22 19.47
Week 6 (N = 244, 227) 29.51 22.91
Week 7 (N= 240, 216) 30.42 22.22
Week 8 (N = 236, 213) 33.05 27.70
Week 9 (N = 232, 214) 34.05 26.17
Week 10 (N = 229, 212) 32.75 26.42
Week 11 (N = 231, 211) 34.20 25.59
Week 12 (N = 227, 209) 37.89 26.79
Week 13 (N = 226, 204) 35.84 27.45
Week 14 (N = 223, 208) 37.67 29.81
Week 15 (N = 196, 187) 39.80 34.22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1633
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.11
Confidence Interval 95%
0.74 to 6.00
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0652
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.92
Confidence Interval 95%
0.96 to 3.85
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0039
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.20
Confidence Interval 95%
1.29 to 3.77
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0382
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.71
Confidence Interval 95%
1.03 to 2.83
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0137
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.86
Confidence Interval 95%
1.14 to 3.05
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0693
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.55
Confidence Interval 95%
0.97 to 2.49
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0349
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.68
Confidence Interval 95%
1.04 to 2.73
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1227
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.44
Confidence Interval 95%
0.91 to 2.29
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0364
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.65
Confidence Interval 95%
1.03 to 2.63
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0667
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.55
Confidence Interval 95%
0.97 to 2.49
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0176
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.77
Confidence Interval 95%
1.10 to 2.84
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0030
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.03
Confidence Interval 95%
1.27 to 3.23
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0256
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.71
Confidence Interval 95%
1.07 to 2.74
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0314
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.66
Confidence Interval 95%
1.05 to 2.64
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis at Week 15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1889
Comments [Not Specified]
Method Gen linear model-logistic link function
Comments Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.38
Confidence Interval 95%
0.85 to 2.21
Estimation Comments [Not Specified]
Time Frame From Day -21 to Day 112 (week 16) i.e. from baseline until 1 day post last taper dose.
Adverse Event Reporting Description The adverse events reporting period was from the signing of the informed consent (at screening) throughout the study including 28 calendar days from the last dose of study medication.
 
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase. Participants randomized to receive placebo
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 (%) # Events Affected / at Risk (%) # Events
Total   2/274 (0.73%)      7/265 (2.64%)    
Cardiac disorders     
Atrial fibrillation * 1  1/274 (0.36%)  1 0/265 (0.00%)  0
Gastrointestinal disorders     
Haemorrhoids * 1  0/274 (0.00%)  0 1/265 (0.38%)  1
Infections and infestations     
Urinary tract infection * 1  1/274 (0.36%)  1 0/265 (0.00%)  0
Injury, poisoning and procedural complications     
Concussion * 1  0/274 (0.00%)  0 1/265 (0.38%)  1
Overdose * 1  0/274 (0.00%)  0 1/265 (0.38%)  1
Post procedural discharge * 1  0/274 (0.00%)  0 1/265 (0.38%)  1
Metabolism and nutrition disorders     
Hypoglycaemia * 1  1/274 (0.36%)  2 0/265 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis * 1  0/274 (0.00%)  0 1/265 (0.38%)  1
Nervous system disorders     
Headache * 1  1/274 (0.36%)  1 0/265 (0.00%)  0
Hypoglycaemic seizure * 1  1/274 (0.36%)  1 0/265 (0.00%)  0
Psychiatric disorders     
Major depression * 1  0/274 (0.00%)  0 1/265 (0.38%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  0/274 (0.00%)  0 1/265 (0.38%)  1
Pneumonia aspiration * 1  0/274 (0.00%)  0 1/265 (0.38%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   75/274 (27.37%)      33/265 (12.45%)    
Gastrointestinal disorders     
Nausea * 1  14/274 (5.11%)  15 8/265 (3.02%)  8
General disorders     
Fatigue * 1  14/274 (5.11%)  16 10/265 (3.77%)  10
Nervous system disorders     
Dizziness * 1  40/274 (14.60%)  51 11/265 (4.15%)  13
Somnolence * 1  27/274 (9.85%)  31 9/265 (3.40%)  10
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 18.1
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 Clinical Trials.gov Call Center
Organization: Pfizer, Inc
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01701362     History of Changes
Other Study ID Numbers: A0081279
2012-003304-12 ( EudraCT Number )
First Submitted: October 3, 2012
First Posted: October 5, 2012
Results First Submitted: July 20, 2016
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017