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Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00830167
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : June 1, 2012
Last Update Posted : June 1, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: Placebo
Drug: Pregabalin
Enrollment 498
Recruitment Details  
Pre-assignment Details Participants were administered placebo tablet in single blind manner and evaluated for the inclusion/exclusion criteria during the 1-week screening phase. Participants who demonstrated a high response to placebo, i.e., <=30% decrease on the VAS, were discontinued from the study at the end of the screening phase.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description Placebo was administered twice a day for 15 weeks. Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Period Title: Overall Study
Started 248 [1] 250 [1]
Completed 208 207
Not Completed 40 43
Reason Not Completed
Lack of Efficacy             26             10
Adverse Event             8             24
Not meeting entrance criteria             2             5
Withdrawal by Subject             2             0
Lost to Follow-up             0             1
Protocol Violation             0             1
Other             2             2
[1]
Treated
Arm/Group Title Placebo Pregabalin Total
Hide Arm/Group Description Placebo was administered twice a day for 15 weeks. Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase. Total of all reporting groups
Overall Number of Baseline Participants 248 250 498
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 248 participants 250 participants 498 participants
<18 years 0 0 0
Between 18 years and 44 years 104 101 205
Between 45 years and 64 years 123 125 248
>=65 years 21 24 45
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 250 participants 498 participants
Female
217
  87.5%
226
  90.4%
443
  89.0%
Male
31
  12.5%
24
   9.6%
55
  11.0%
1.Primary Outcome
Title Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
Hide Description Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.03  (0.12) -1.48  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments The analysis was conducted using 1-sided test with the significance level of 0.025. Actual significance level was calculated based on O’Brien-Fleming type alpha spending function of Lan and DeMets (1983).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.78 to -0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Was Categorized as “Improved (Very Much Improved, Much Improved, or a Minimally Improved)” According to the Patient Global Impressions of Change (PGIC)
Hide Description PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale.
Time Frame Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Measure Type: Number
Unit of Measure: Percentage of participants
62.1 70.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that there was a difference between the pregabalin and the placebo groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments The analysis was conducted using 2-sided test with the significance level of 0.05.
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance
Hide Description MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-8.13  (1.31) -17.62  (1.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.48
Confidence Interval (2-Sided) 95%
-13.12 to -5.85
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.85
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring
Hide Description MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.61  (1.33) 3.37  (1.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9958
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.98
Confidence Interval (2-Sided) 95%
1.29 to 8.68
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.88
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache
Hide Description MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-3.02  (1.36) -8.01  (1.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.99
Confidence Interval (2-Sided) 95%
-8.77 to -1.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.92
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep
Hide Description MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
0.17  (0.06) 0.46  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.11 to 0.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy
Hide Description MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
8.02  (1.41) 15.50  (1.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.48
Confidence Interval (2-Sided) 95%
3.58 to 11.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.99
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence
Hide Description MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-4.66  (1.29) 6.65  (1.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.31
Confidence Interval (2-Sided) 95%
7.74 to 14.87
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.82
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index
Hide Description MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-7.07  (0.96) -10.06  (0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0137
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.99
Confidence Interval (2-Sided) 95%
-5.65 to -0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.35
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint
Hide Description MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night.
Time Frame Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Measure Type: Number
Unit of Measure: Participants
53 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0687
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
0.90 to 2.35
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Sleep Quality Score at Endpoint
Hide Description Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.79  (0.12) -1.52  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-1.06 to -0.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-7.26  (1.08) -10.59  (1.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0144
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.33
Confidence Interval (2-Sided) 95%
-6.31 to -0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.52
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.19  (0.11) -0.47  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0376
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.59 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.82  (0.17) -1.45  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.12 to -0.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.25
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.30  (0.15) -0.31  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4768
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.42 to 0.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.00  (0.15) -1.32  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0729
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.74 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.06  (0.15) -1.46  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0238
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.81 to 0.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.94  (0.14) -1.43  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.89 to -0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.97  (0.15) -1.56  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-1.01 to -0.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.90  (0.15) -1.05  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2568
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.57 to 0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.64  (0.16) -0.92  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1011
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.72 to 0.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression
Hide Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.51  (0.14) -0.55  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4165
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.44 to 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning
Hide Description Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
4.72  (0.93) 9.01  (0.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.29
Confidence Interval (2-Sided) 95%
1.70 to 6.88
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.32
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical
Hide Description Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
8.36  (1.30) 10.04  (1.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1805
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.68
Confidence Interval (2-Sided) 95%
-1.93 to 5.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.84
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain
Hide Description Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
9.50  (1.06) 11.65  (1.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0770
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.15
Confidence Interval (2-Sided) 95%
-0.81 to 5.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.50
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception
Hide Description Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
2.83  (0.85) 4.66  (0.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0648
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.83
Confidence Interval (2-Sided) 95%
-0.54 to 4.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.20
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning
Hide Description Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
6.84  (1.38) 8.43  (1.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2068
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
-2.23 to 5.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.94
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional
Hide Description Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
3.50  (1.36) 3.27  (1.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5480
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-4.00 to 3.54
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.92
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality
Hide Description Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
5.12  (1.22) 9.53  (1.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.42
Confidence Interval (2-Sided) 95%
1.04 to 7.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.72
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health
Hide Description Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
3.33  (0.98) 5.97  (0.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0287
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.64
Confidence Interval (2-Sided) 95%
-0.08 to 5.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.39
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety
Hide Description Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.09  (0.18) -0.57  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0262
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.97 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.25
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression
Hide Description Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 247 249
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
0.00  (0.20) -0.29  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1561
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.83 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint
Hide Description The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
Placebo was administered twice a day for 15 weeks.
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-14.11  (1.45) -20.30  (1.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin
Comments The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments The analysis was conducted using 1-sided test with the significance level of 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.19
Confidence Interval (2-Sided) 95%
-10.20 to -2.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.04
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description Placebo was administered twice a day for 15 weeks. Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
All-Cause Mortality
Placebo Pregabalin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pregabalin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/248 (0.00%)   1/250 (0.40%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/248 (0.00%)  1/250 (0.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Pregabalin
Affected / at Risk (%) Affected / at Risk (%)
Total   113/248 (45.56%)   195/250 (78.00%) 
Eye disorders     
Vision blurred  1  3/248 (1.21%)  13/250 (5.20%) 
Gastrointestinal disorders     
Constipation  1  17/248 (6.85%)  36/250 (14.40%) 
General disorders     
Feeling abnormal  1  3/248 (1.21%)  20/250 (8.00%) 
Oedema peripheral  1  3/248 (1.21%)  18/250 (7.20%) 
Infections and infestations     
Nasopharyngitis  1  45/248 (18.15%)  45/250 (18.00%) 
Investigations     
Weight increased  1  9/248 (3.63%)  39/250 (15.60%) 
Nervous system disorders     
Dizziness  1  15/248 (6.05%)  74/250 (29.60%) 
Headache  1  15/248 (6.05%)  15/250 (6.00%) 
Somnolence  1  45/248 (18.15%)  116/250 (46.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00830167     History of Changes
Other Study ID Numbers: A0081208
First Submitted: January 26, 2009
First Posted: January 27, 2009
Results First Submitted: April 30, 2012
Results First Posted: June 1, 2012
Last Update Posted: June 1, 2012