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Adolescent Fibromyalgia Study

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: NCT01020474
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : June 25, 2015
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: placebo
Drug: pregabalin (Lyrica)
Enrollment 107
Recruitment Details A total of 147 participants were screened, 107 participants were randomized to treatment. The 107 randomized participants were recruited in 4 countries at 23 study centers.
Pre-assignment Details This study consisted of 4 phases, screening (1 Week), dose optimization (3 Weeks), fixed dose (12 Weeks) and follow-up (1 Week).
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose. Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
Period Title: Overall Study
Started 54 53
Completed 44 36
Not Completed 10 17
Reason Not Completed
Adverse Event             4             4
Protocol Violation             0             2
Withdrawal by Subject             5             7
Other Reasons             1             1
Insufficient Clinical Response             0             3
Arm/Group Title Pregabalin Placebo Total
Hide Arm/Group Description Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose. Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 54 53 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 53 participants 107 participants
14.6  (1.2) 14.7  (1.2) 14.7  (1.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 107 participants
Female
48
  88.9%
44
  83.0%
92
  86.0%
Male
6
  11.1%
9
  17.0%
15
  14.0%
1.Primary Outcome
Title Change From Baseline to Week 15 in Mean Pain Diary Score
Hide Description The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) population consists of all randomized participants who received at least one dose of study medication.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
Overall Number of Participants Analyzed 54 51
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.60  (0.32) -0.94  (0.31)
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 0.121
Comments Missing data for week 15 mean pain score are imputed based on distribution of baseline pain scores if participants discontinue due to adverse events/ abnormal laboratory test results or lack of efficacy.
Method ANCOVA
Comments Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.51 to 0.18
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
Hide Description Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consists of all randomized participants who received at least one dose of study medication. Last observation carried forward (LOCF) for participants with missing Week 15 mean pain score, i.e., the endpoint mean pain score.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
Overall Number of Participants Analyzed 54 50
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.13  (0.30) -0.94  (0.31)
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 0.655
Comments [Not Specified]
Method ANCOVA
Comments Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-1.00 to 0.63
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Hide Description Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame Baseline to Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consists of all randomized participants who received at least one dose of study medication.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
Overall Number of Participants Analyzed 54 51
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 1 (N= 52, 49) -0.48  (0.25) -0.41  (0.26)
Week 2 (N= 54, 47) -1.11  (0.25) -0.48  (0.26)
Week 3 (N= 52, 44) -1.27  (0.25) -0.45  (0.26)
Week 4 (N= 50, 46) -1.45  (0.25) -0.55  (0.26)
Week 5 (N= 49, 44) -1.27  (0.25) -0.59  (0.26)
Week 6 (N= 49, 44) -1.47  (0.25) -0.51  (0.27)
Week 7 (N= 48, 42) -1.67  (0.25) -0.77  (0.27)
Week 8 (N= 46, 44) -1.65  (0.25) -0.59  (0.27)
Week 9 (N= 46, 42) -1.61  (0.26) -0.66  (0.27)
Week 10 (N= 45, 40) -1.82  (0.26) -0.85  (0.27)
Week 11 (N= 44, 38) -1.93  (0.26) -1.07  (0.28)
Week 12 (N= 43, 34) -1.75  (0.26) -0.78  (0.28)
Week 13 (N= 42, 33) -1.75  (0.27) -1.01  (0.29)
Week 14 (N= 41, 34) -2.01  (0.27) -1.11  (0.29)
Week 15 (N= 35, 33) -1.90  (0.28) -1.16  (0.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.842
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.75 to 0.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.32 to 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 3.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-1.51 to -0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-1.59 to -0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-1.38 to 0.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-1.66 to -0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.89
Confidence Interval (2-Sided) 95%
-1.60 to -0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-1.77 to -0.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 9.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-1.67 to -0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.97
Confidence Interval (2-Sided) 95%
-1.69 to -0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 11.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-1.59 to -0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.97
Confidence Interval (2-Sided) 95%
-1.71 to -0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 13.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.74
Confidence Interval (2-Sided) 95%
-1.49 to 0.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-1.66 to -0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 15.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.74
Confidence Interval (2-Sided) 95%
-1.51 to 0.03
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Hide Description Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".
Time Frame Baseline to Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consists of all randomized participants who received at least one dose of study medication.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
Overall Number of Participants Analyzed 54 51
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 1 (N= 52, 49) -0.52  (0.25) -0.30  (0.26)
Week 2 (N= 54, 47) -0.84  (0.25) -0.65  (0.26)
Week 3 (N= 52, 44) -0.89  (0.25) -0.44  (0.26)
Week 4 (N= 50, 46) -1.03  (0.25) -0.54  (0.26)
Week 5 (N= 49, 44) -0.99  (0.25) -0.61  (0.27)
Week 6 (N= 49, 44) -1.18  (0.25) -0.54  (0.27)
Week 7 (N= 48, 42) -1.30  (0.25) -0.81  (0.27)
Week 8 (N= 46, 44) -1.43  (0.25) -0.42  (0.27)
Week 9 (N= 46, 42) -1.38  (0.26) -0.81  (0.27)
Week 10 (N= 45, 40) -1.43  (0.26) -0.66  (0.27)
Week 11 (N= 44, 38) -1.39  (0.26) -0.95  (0.28)
Week 12 (N= 43, 34) -1.38  (0.26) -0.77  (0.28)
Week 13 (N= 42, 33) -1.34  (0.27) -1.00  (0.29)
Week 14 (N= 41, 34) -1.36  (0.27) -0.94  (0.29)
Week 15 (N= 35, 33) -1.25  (0.28) -1.08  (0.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.540
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.90 to 0.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.593
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.87 to 0.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 3.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.206
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-1.13 to 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-1.18 to 0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.280
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-1.08 to 0.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-1.34 to 0.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-1.21 to 0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.01
Confidence Interval (2-Sided) 95%
-1.73 to -0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 9.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-1.29 to 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-1.49 to -0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 11.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.246
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-1.16 to 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.36 to 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 13.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.376
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-1.09 to 0.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.285
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-1.18 to 0.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis of Week 15.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.663
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.95 to 0.61
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)
Hide Description The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consists of all randomized participants who received at least one dose of study medication. Baseline observation carried forward (BOCF) for participants with missing Week 15 mean pain score.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
Overall Number of Participants Analyzed 54 53
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.64  (0.31) -0.77  (0.30)
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 0.037
Comments [Not Specified]
Method ANCOVA
Comments Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.68 to -0.05
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15
Hide Description At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consists of all randomized participants who received at least one dose of study medication. Modified baseline observation carried forward (mBOCF) for participants with missing Week 15 mean pain score.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: percentage of participants
42.6 38.8
Hide Statistical Analysis 1
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 0.694
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.53 to 2.58
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15
Hide Description At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consists of all randomized participants who received at least one dose of study medication. mBOCF for participants with missing Week 15 mean pain score.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: percentage of participants
20.4 10.2
Hide Statistical Analysis 1
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 0.162
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.25
Confidence Interval (2-Sided) 95%
0.72 to 7.02
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Proportion of Patient Global Impression Change (PGIC) at Week 15
Hide Description Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consists of all randomized participants who received at least one dose of study medication.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
Overall Number of Participants Analyzed 49 44
Measure Type: Number
Unit of Measure: percentage of participants
Very much improved 16.3 2.3
Much improved 36.7 27.3
Minimally improved 22.4 27.3
No change 18.4 38.6
Minimally worse 6.1 2.3
Much worse 0 2.3
Very much worse 0 0
Hide Statistical Analysis 1
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 0.013
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value uses the row mean score statistic based on Cochran Mantel Haenszel (CMH) test with modified ridit transformation.
Time Frame Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Adverse Event Reporting Description Participants are only counted once per treatment for each event.
 
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose. Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
All-Cause Mortality
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/54 (1.85%)   0/53 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/54 (1.85%)  0/53 (0.00%) 
Psychiatric disorders     
Major depression * 1  1/54 (1.85%)  0/53 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   33/54 (61.11%)   27/53 (50.94%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  1/54 (1.85%)  3/53 (5.66%) 
Abdominal pain * 1  3/54 (5.56%)  1/53 (1.89%) 
Abdominal pain upper * 1  0/54 (0.00%)  3/53 (5.66%) 
Dry mouth * 1  2/54 (3.70%)  3/53 (5.66%) 
Nausea * 1  12/54 (22.22%)  5/53 (9.43%) 
Vomiting * 1  3/54 (5.56%)  4/53 (7.55%) 
General disorders     
Fatigue * 1  8/54 (14.81%)  4/53 (7.55%) 
Pyrexia * 1  4/54 (7.41%)  3/53 (5.66%) 
Infections and infestations     
Pharyngitis streptococcal * 1  0/54 (0.00%)  4/53 (7.55%) 
Upper respiratory tract infection * 1  3/54 (5.56%)  4/53 (7.55%) 
Injury, poisoning and procedural complications     
Ligament sprain * 1  3/54 (5.56%)  0/53 (0.00%) 
Investigations     
Weight increased * 1  9/54 (16.67%)  0/53 (0.00%) 
Metabolism and nutrition disorders     
Increased appetite * 1  3/54 (5.56%)  1/53 (1.89%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/54 (1.85%)  4/53 (7.55%) 
Back pain * 1  3/54 (5.56%)  5/53 (9.43%) 
Neck pain * 1  0/54 (0.00%)  3/53 (5.66%) 
Pain in extremity * 1  4/54 (7.41%)  0/53 (0.00%) 
Nervous system disorders     
Balance disorder * 1  3/54 (5.56%)  0/53 (0.00%) 
Dizziness * 1  16/54 (29.63%)  7/53 (13.21%) 
Headache * 1  10/54 (18.52%)  10/53 (18.87%) 
Migraine * 1  2/54 (3.70%)  3/53 (5.66%) 
Somnolence * 1  5/54 (9.26%)  2/53 (3.77%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/54 (1.85%)  4/53 (7.55%) 
Nasal congestion * 1  2/54 (3.70%)  3/53 (5.66%) 
Oropharyngeal pain * 1  4/54 (7.41%)  2/53 (3.77%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01020474    
Other Study ID Numbers: A0081180
2010-019521-34 ( EudraCT Number )
First Submitted: November 23, 2009
First Posted: November 25, 2009
Results First Submitted: May 26, 2015
Results First Posted: June 25, 2015
Last Update Posted: June 25, 2015