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Trial record 58 of 424 for:    Pregabalin

A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

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: NCT01432236
Recruitment Status : Completed
First Posted : September 12, 2011
Results First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: Pregabalin
Drug: placebo
Enrollment 197
Recruitment Details In this double blind, crossover study, a total of 197 participants were randomized to either pregabalin/placebo or placebo/pregabalin treatment sequence. Of these, 193 took at least one dose of study medication. Four randomized participants never took study medication. Randomized participants were recruited from 4 countries at 38 study centers.
Pre-assignment Details Participants with mean Numeric Rating Scale (NRS) pain score of ≥4 at Baseline and meeting all other inclusion/exclusion criteria were randomly assigned to receive double blind treatment with either pregabalin followed by placebo with background antidepressant or placebo followed by pregabalin with background antidepressant.
Arm/Group Title Pregabalin/Placebo Placebo/Pregabalin
Hide Arm/Group Description Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods. Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Period Title: Overall Study
Started 96 97
Completed 70 79
Not Completed 26 18
Arm/Group Title Pregabalin/Placebo Placebo/Pregabalin Total
Hide Arm/Group Description Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods. Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods. Total of all reporting groups
Overall Number of Baseline Participants 96 97 193
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 96 participants 97 participants 193 participants
< 18 Years 0 0 0
18-44 Years 22 29 51
45-64 Years 69 60 129
>= 65 Years 5 8 13
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 97 participants 193 participants
Female
87
  90.6%
93
  95.9%
180
  93.3%
Male
9
   9.4%
4
   4.1%
13
   6.7%
1.Primary Outcome
Title Mean NRS Pain Score at End of Period.
Hide Description The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively.
Time Frame End of each period, at Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 179 173
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
4.84  (0.15) 5.45  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analysis was done using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Primary analysis was two-sided and performed at the 0.05 significance level.
Method Mixed Models Analysis
Comments Satterthwaite’s approximation was used to estimate denominator degrees of freedom.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.91 to -0.31
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.
Hide Description This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin/Placebo Placebo/Pregabalin
Hide Arm/Group Description:
Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process in period 2. There was a 2-week single-blind taper/washout period between treatment periods
Overall Number of Participants Analyzed 96 97
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Total (N=96, 96) 63.83  (11.58) 62.75  (12.51)
Physical Impairment (N=96, 97) 4.58  (2.10) 4.44  (2.14)
Feel Good (N=96, 97) 7.78  (2.47) 7.43  (2.32)
Work Missed (N=96, 97) 3.38  (2.88) 3.49  (3.21)
Do Work (N=96, 97) 6.61  (2.03) 6.38  (2.21)
Pain (N=96, 96) 6.98  (1.25) 7.09  (1.32)
Fatigue (N=96, 97) 8.17  (1.37) 8.08  (1.58)
Rested (N=96, 97) 7.90  (1.51) 7.82  (1.96)
Stiffness (N=96, 97) 7.56  (1.76) 7.64  (1.58)
Anxiety (N=96, 97) 5.65  (2.73) 5.60  (2.59)
Depression (N=96, 97) 5.23  (2.64) 4.84  (2.55)
3.Secondary Outcome
Title FIQ Score at End of Period.
Hide Description This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).
Time Frame End of each period, at Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. Different number (N) for each category represents participants that were actually treated with pregabalin and placebo during the study.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 181 177
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Total (N=176, 172) 43.78  (1.42) 50.38  (1.43)
Physical impairment (N=176, 173) 3.35  (0.17) 3.77  (0.17)
Feel good (N=176, 173) 4.69  (0.23) 5.53  (0.23)
Work missed (N=176 , 173) 2.02  (0.21) 2.62  (0.21)
Do work (N=176, 172) 4.56  (0.20) 5.31  (0.20)
Pain (N=176, 173) 4.91  (0.17) 5.54  (0.17)
Fatigue (N=176, 173) 6.32  (0.19) 6.76  (0.19)
Rested (N=176, 173) 5.64  (0.19) 6.41  (0.19)
Stiffness (N=176, 173) 5.24  (0.19) 5.95  (0.19)
Anxiety (N=176, 173) 3.80  (0.20) 4.35  (0.21)
Depression (N=176, 173) 3.20  (0.20) 4.13  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for the FIQ total score. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.60
Confidence Interval (2-Sided) 95%
-9.33 to -3.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for parameter 'physical impairment'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.74 to -0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for the parameter 'feel good'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.85
Confidence Interval (2-Sided) 95%
-1.36 to -0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above for parameter 'work missed'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0050
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
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
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for the parameter 'do work'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-1.14 to -0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for the parameter 'pain'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
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%
-1.00 to -0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for the parameter 'fatigue'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0315
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
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%
-0.85 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for the parameter 'rested'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.17 to -0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for the parameter 'stiffness'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-1.11 to -0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for the parameter 'anxiety'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.93 to -0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for the parameter 'depression'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.32 to -0.53
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at the End of Period 1.
Hide Description PGIC: 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).
Time Frame End of Period 1 at Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 93 93
Measure Type: Number
Unit of Measure: Percentage of participants
Very much improved 10.8 4.3
Much improved 35.5 25.8
Minimally improved 28.0 40.9
No change 17.2 21.5
Minimally worse 4.3 6.5
Much worse 3.2 1.1
Very much worse 1.1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments The PGIC variable was analyzed using Cochran Mantel-Haenszel (CMH) test with modified ridit transformation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0637
Comments This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary.
Hide Description Participant with at least a 30% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 30% responder, for the respective period. Similarly, a subject with at least a 50% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 50% responder, for the respective period.
Time Frame Visits 2, 6, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 179 173
Measure Type: Number
Unit of Measure: Percentage of participants
30% Responders 45.3 27.7
50% Responders 26.0 15.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for 30% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Statistical analysis presented above is for 50% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0205
Comments This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Regression, Logistic
Comments [Not Specified]
6.Secondary Outcome
Title Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.
Hide Description Subjective Sleep Questionnaire included 5 items: participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective rating of quality of sleep during the past night was done by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses was therefore 0-10.
Time Frame End of each period, at Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 179 173
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.15  (0.14) 5.57  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-subject error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.31 to 0.84
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period.
Hide Description Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective wake after sleep onset was the subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening.
Time Frame End of each period, at Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 179 173
Least Squares Mean (Standard Error)
Unit of Measure: Minutes
33.38  (2.73) 41.18  (2.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.81
Confidence Interval (2-Sided) 95%
-12.66 to -2.96
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period.
Hide Description Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective latency to sleep onset was the subjective estimate of the amount of time to fall asleep after lights out.
Time Frame End of each period, at Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 179 173
Least Squares Mean (Standard Error)
Unit of Measure: Minutes
33.54  (2.68) 39.33  (2.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0117
Comments This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.80
Confidence Interval (2-Sided) 95%
-10.29 to -1.31
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period.
Hide Description Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.
Time Frame End of each period, at Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 179 173
Least Squares Mean (Standard Error)
Unit of Measure: Minutes
422.98  (5.42) 414.63  (5.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0511
Comments This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.35
Confidence Interval (2-Sided) 95%
-0.04 to 16.74
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period.
Hide Description Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective number of awakenings after sleep onset was the subjective estimate of the total number of times the participant awakened during the night until final awakening.
Time Frame End of each period, at Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 179 173
Least Squares Mean (Standard Error)
Unit of Measure: Number of times awakened
0.48  (0.07) 0.61  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors. Analyzed as a count variable using a generalized linear model assuming a Poisson distribution and utilizing a log link transformation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1139
Comments This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.29 to 0.03
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS) at Baseline.
Hide Description HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame Baseline
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ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin/Placebo Placebo/Pregabalin
Hide Arm/Group Description:
Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 96 97
Mean (Standard Deviation)
Unit of Measure: Units on a scale
HADS-A (anxiety) 8.67  (3.95) 7.97  (3.77)
HADS-D (depression) 8.34  (3.59) 7.73  (3.64)
12.Secondary Outcome
Title HADS at End of Period.
Hide Description HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame End of each period, at Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 176 173
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
HADS-A (anxiety) 6.01  (0.28) 6.96  (0.28)
HADS-D (depression) 6.17  (0.31) 7.05  (0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analysis presented in the above table is for HADS-A (anxiety). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-1.40 to -0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analysis presented in the above table is for HADS-D (depression). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and subject within sequence and within-subject error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.37 to -0.39
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline.
Hide Description EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
Time Frame Baseline
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Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin/Placebo Placebo/Pregabalin
Hide Arm/Group Description:
Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 96 97
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.40  (0.31) 0.37  (0.33)
14.Secondary Outcome
Title EQ-5D Score at End of Period.
Hide Description EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
Time Frame End of each period, at Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 176 172
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.58  (0.02) 0.56  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3854
Comments Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.02 to 0.06
Estimation Comments [Not Specified]
15.Other Pre-specified Outcome
Title PGIC at the End of Period 2.
Hide Description PGIC: 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). Because of the crossover design and PGIC recall period (since starting study medication), the Period 1 PGIC data were felt to provide the clearest comparison across treatments, whereas Period 2 PGIC data were felt to have a more complex interpretation. Thus PGIC at End of Period 2 was separately analyzed from PGIC at End of Period 1.
Time Frame End of Period 2 at Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 82 81
Measure Type: Number
Unit of Measure: Percentage of Participants
Very much improved 18.3 8.6
Much improved 34.1 25.9
Minimally improved 28.0 38.3
No change 11.0 14.8
Minimally worse 6.1 8.6
Much worse 1.2 2.5
Very much worse 1.2 1.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments The PGIC variable was analyzed using CMH test with modified ridit transformation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1160
Comments This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
16.Other Pre-specified Outcome
Title Mean Patient Static Global Assessment (PSGA) Score at Baseline.
Hide Description PSGA was a single-item self-rated instrument that measured the participant’s overall status on an 11-point NRS ranging from 0 (very poor) to 10 (very good).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin/Placebo Placebo/Pregabalin
Hide Arm/Group Description:
Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 96 97
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.35  (2.04) 4.46  (1.92)
17.Other Pre-specified Outcome
Title Mean PSGA Score at End of Period.
Hide Description PSGA was a single-item self-rated instrument that measured the participant’s overall status on an 11-point numeric rating scale (NRS) ranging from 0 (very poor) to 10 (very good).
Time Frame End of each period, at Weeks 6 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 176 172
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
5.83  (0.17) 5.27  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0085
Comments Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.14 to 0.97
Estimation Comments [Not Specified]
18.Other Pre-specified Outcome
Title Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline.
Hide Description C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3) (“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).
Time Frame Baseline
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Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin/Placebo Placebo/Pregabalin
Hide Arm/Group Description:
Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 96 97
Measure Type: Number
Unit of Measure: Participants
Wish to be Dead 3 1
Non-Specific Thoughts 0 1
Without Intent to Act 0 0
Some Intent to Act 0 0
Specific Plan and Intent 0 0
Actual Attempt 0 0
Non-Suicidal Self-Injurious Behavior 0 0
Interrupted Attempt 0 0
Aborted Attempt 0 0
Preparatory Acts or Behavior 0 0
Suicidal Behavior Present 0 0
Completed Suicide 0 0
19.Other Pre-specified Outcome
Title Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline.
Hide Description C-SSRS assessed whether participant experienced following:completed suicide (1), suicide attempt (2) (response of Yes on “actual attempt”), preparatory acts toward imminent suicidal behavior (3) (Yes on “preparatory acts or behavior”), suicidal ideation (4) (Yes on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on “Has subject engaged in non-suicidal self-injurious behavior”). Below table indicated one participant (10141023) treated with Pregabalin reported preparatory act. However upon study unblinding it was clarified that preparatory act occurred while the participant was taking placebo. Since preparatory act was reported at first visit of Period 2, by convention statistical summaries classified this under Pregabalin treatment.
Time Frame From Visit 3 to Visit 14
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Overall Number of Participants Analyzed 181 177
Measure Type: Number
Unit of Measure: Participants
Wish to be Dead 10 8
Non-Specific Thoughts 3 1
Without Intent to Act 2 0
Some Intent to Act 0 0
Specific Plan and Intent 0 0
Actual Attempt 0 0
Non-Suicidal Self-Injurious Behavior 0 0
Interrupted Attempt 0 0
Aborted Attempt 0 0
Preparatory Acts or Behavior 1 0
Suicidal Behavior Present 1 0
Completed Suicide 0 0
20.Other Pre-specified Outcome
Title Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline.
Hide Description WPAI-SHP assessed work productivity and impairment. It was a participant-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past 7 days. Subscale scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Each subscale score was expressed as an impairment percentage (0-100) where higher numbers indicated greater impairment and less productivity.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title All Participants
Hide Arm/Group Description:
All randomized participants were included in this analysis.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Percent Absenteeism (N= 86) 15.22  (25.36)
Percent Presenteeism (N= 83) 53.98  (21.52)
Percent Overall Work Impairment (N= 82) 57.96  (23.42)
Percent Activity Impairment (N=193) 64.97  (18.77)
21.Other Pre-specified Outcome
Title Health Utilization Assessment (Total Office Visits, Number of Hospitalizations and Number of Emergency Room Visits) at Baseline.
Hide Description The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title All Participants
Hide Arm/Group Description:
All randomized participants were included in this analysis.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: Visits
Total office visits (N= 193) 5.01  (6.6)
Number of hospitalizations (N= 0) NA [1]   (NA)
Number of emergency room visits (N= 12) 1.83  (1.0)
[1]
Could not be calculated as N=0
22.Other Pre-specified Outcome
Title Health Utilization Assessment (Time for Help no Payment) at Baseline.
Hide Description The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services. 'Time for help no payment' refers to time other people spent without receiving payment to help with activities the patient cannot perform due to fibromyalgia.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.
Arm/Group Title All Participants
Hide Arm/Group Description:
All randomized participants were included in this analysis.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: Hours
50.37  (98.1)
Time Frame Up to Week 16
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 Pregabalin Placebo
Hide Arm/Group Description The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods. The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
All-Cause Mortality
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/181 (1.66%)   1/177 (0.56%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  1/181 (0.55%)  0/177 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain neoplasm malignant * 1  0/181 (0.00%)  1/177 (0.56%) 
Psychiatric disorders     
Anxiety * 1  1/181 (0.55%)  0/177 (0.00%) 
Surgical and medical procedures     
Detoxification * 1  1/181 (0.55%)  0/177 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   139/181 (76.80%)   106/177 (59.89%) 
Blood and lymphatic system disorders     
Neutrophilia * 1  0/181 (0.00%)  1/177 (0.56%) 
Cardiac disorders     
Palpitations * 1  0/181 (0.00%)  1/177 (0.56%) 
Ear and labyrinth disorders     
Ear pain * 1  0/181 (0.00%)  1/177 (0.56%) 
Tinnitus * 1  0/181 (0.00%)  1/177 (0.56%) 
Vertigo * 1  2/181 (1.10%)  0/177 (0.00%) 
Endocrine disorders     
Inappropriate antidiuretic hormone secretion * 1  0/181 (0.00%)  1/177 (0.56%) 
Eye disorders     
Conjunctival haemorrhage * 1  0/181 (0.00%)  1/177 (0.56%) 
Dry eye * 1  3/181 (1.66%)  0/177 (0.00%) 
Eye disorder * 1  1/181 (0.55%)  0/177 (0.00%) 
Eyelid oedema * 1  0/181 (0.00%)  1/177 (0.56%) 
Vision blurred * 1  7/181 (3.87%)  3/177 (1.69%) 
Visual impairment * 1  1/181 (0.55%)  0/177 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  0/181 (0.00%)  1/177 (0.56%) 
Abdominal distension * 1  2/181 (1.10%)  1/177 (0.56%) 
Abdominal pain * 1  3/181 (1.66%)  3/177 (1.69%) 
Abdominal pain upper * 1  1/181 (0.55%)  4/177 (2.26%) 
Constipation * 1  19/181 (10.50%)  4/177 (2.26%) 
Dental caries * 1  1/181 (0.55%)  0/177 (0.00%) 
Diarrhoea * 1  16/181 (8.84%)  7/177 (3.95%) 
Dry mouth * 1  12/181 (6.63%)  1/177 (0.56%) 
Dyspepsia * 1  1/181 (0.55%)  1/177 (0.56%) 
Dysphagia * 1  1/181 (0.55%)  0/177 (0.00%) 
Flatulence * 1  4/181 (2.21%)  2/177 (1.13%) 
Gastrooesophageal reflux disease * 1  1/181 (0.55%)  0/177 (0.00%) 
Haemorrhoids * 1  1/181 (0.55%)  0/177 (0.00%) 
Irritable bowel syndrome * 1  0/181 (0.00%)  1/177 (0.56%) 
Lip swelling * 1  1/181 (0.55%)  0/177 (0.00%) 
Nausea * 1  17/181 (9.39%)  12/177 (6.78%) 
Odynophagia * 1  0/181 (0.00%)  1/177 (0.56%) 
Paraesthesia oral * 1  3/181 (1.66%)  0/177 (0.00%) 
Salivary gland pain * 1  0/181 (0.00%)  1/177 (0.56%) 
Toothache * 1  1/181 (0.55%)  1/177 (0.56%) 
Vomiting * 1  1/181 (0.55%)  5/177 (2.82%) 
General disorders     
Asthenia * 1  1/181 (0.55%)  2/177 (1.13%) 
Chest discomfort * 1  0/181 (0.00%)  1/177 (0.56%) 
Chest pain * 1  1/181 (0.55%)  2/177 (1.13%) 
Crying * 1  1/181 (0.55%)  0/177 (0.00%) 
Cyst * 1  0/181 (0.00%)  1/177 (0.56%) 
Energy increased * 1  1/181 (0.55%)  0/177 (0.00%) 
Fatigue * 1  12/181 (6.63%)  8/177 (4.52%) 
Feeling abnormal * 1  5/181 (2.76%)  0/177 (0.00%) 
Feeling drunk * 1  1/181 (0.55%)  0/177 (0.00%) 
Feeling hot * 1  1/181 (0.55%)  0/177 (0.00%) 
Feeling jittery * 1  2/181 (1.10%)  0/177 (0.00%) 
Gait disturbance * 1  3/181 (1.66%)  0/177 (0.00%) 
Hunger * 1  3/181 (1.66%)  1/177 (0.56%) 
Inflammation * 1  1/181 (0.55%)  0/177 (0.00%) 
Irritability * 1  3/181 (1.66%)  1/177 (0.56%) 
Malaise * 1  1/181 (0.55%)  0/177 (0.00%) 
Mucosal dryness * 1  1/181 (0.55%)  0/177 (0.00%) 
Non-cardiac chest pain * 1  0/181 (0.00%)  1/177 (0.56%) 
Oedema peripheral * 1  7/181 (3.87%)  3/177 (1.69%) 
Pain * 1  1/181 (0.55%)  0/177 (0.00%) 
Pyrexia * 1  0/181 (0.00%)  4/177 (2.26%) 
Swelling * 1  1/181 (0.55%)  0/177 (0.00%) 
Hepatobiliary disorders     
Hepatomegaly * 1  0/181 (0.00%)  1/177 (0.56%) 
Immune system disorders     
Seasonal allergy * 1  0/181 (0.00%)  1/177 (0.56%) 
Infections and infestations     
Bronchitis * 1  1/181 (0.55%)  2/177 (1.13%) 
Bronchitis viral * 1  0/181 (0.00%)  1/177 (0.56%) 
Cystitis * 1  0/181 (0.00%)  1/177 (0.56%) 
Ear infection * 1  1/181 (0.55%)  2/177 (1.13%) 
Folliculitis * 1  0/181 (0.00%)  1/177 (0.56%) 
Gastroenteritis * 1  0/181 (0.00%)  3/177 (1.69%) 
Gastroenteritis viral * 1  4/181 (2.21%)  2/177 (1.13%) 
Influenza * 1  3/181 (1.66%)  2/177 (1.13%) 
Laryngitis * 1  1/181 (0.55%)  0/177 (0.00%) 
Nasopharyngitis * 1  5/181 (2.76%)  10/177 (5.65%) 
Oral herpes * 1  1/181 (0.55%)  1/177 (0.56%) 
Pharyngitis * 1  1/181 (0.55%)  0/177 (0.00%) 
Pharyngitis streptococcal * 1  0/181 (0.00%)  1/177 (0.56%) 
Rhinitis * 1  1/181 (0.55%)  1/177 (0.56%) 
Sinusitis * 1  1/181 (0.55%)  2/177 (1.13%) 
Tooth infection * 1  1/181 (0.55%)  1/177 (0.56%) 
Upper respiratory tract infection * 1  4/181 (2.21%)  2/177 (1.13%) 
Urinary tract infection * 1  2/181 (1.10%)  1/177 (0.56%) 
Vaginal infection * 1  1/181 (0.55%)  0/177 (0.00%) 
Viral infection * 1  1/181 (0.55%)  0/177 (0.00%) 
Viral upper respiratory tract infection * 1  1/181 (0.55%)  2/177 (1.13%) 
Injury, poisoning and procedural complications     
Arthropod bite * 1  1/181 (0.55%)  0/177 (0.00%) 
Contusion * 1  2/181 (1.10%)  0/177 (0.00%) 
Fall * 1  4/181 (2.21%)  1/177 (0.56%) 
Hand fracture * 1  0/181 (0.00%)  1/177 (0.56%) 
Laceration * 1  0/181 (0.00%)  2/177 (1.13%) 
Ligament sprain * 1  1/181 (0.55%)  0/177 (0.00%) 
Muscle strain * 1  3/181 (1.66%)  0/177 (0.00%) 
Post concussion syndrome * 1  1/181 (0.55%)  0/177 (0.00%) 
Road traffic accident * 1  0/181 (0.00%)  1/177 (0.56%) 
Skeletal injury * 1  1/181 (0.55%)  0/177 (0.00%) 
Tendon rupture * 1  1/181 (0.55%)  0/177 (0.00%) 
Thoracic vertebral fracture * 1  1/181 (0.55%)  0/177 (0.00%) 
Tooth fracture * 1  1/181 (0.55%)  0/177 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  1/181 (0.55%)  0/177 (0.00%) 
Blood glucose increased * 1  1/181 (0.55%)  0/177 (0.00%) 
Blood pressure increased * 1  0/181 (0.00%)  3/177 (1.69%) 
Eosinophil count increased * 1  0/181 (0.00%)  1/177 (0.56%) 
Urine output decreased * 1  1/181 (0.55%)  0/177 (0.00%) 
Weight increased * 1  16/181 (8.84%)  3/177 (1.69%) 
Metabolism and nutrition disorders     
Fluid retention * 1  2/181 (1.10%)  0/177 (0.00%) 
Folate deficiency * 1  0/181 (0.00%)  1/177 (0.56%) 
Food craving * 1  1/181 (0.55%)  0/177 (0.00%) 
Hyperglycaemia * 1  1/181 (0.55%)  0/177 (0.00%) 
Hyperlipidaemia * 1  1/181 (0.55%)  0/177 (0.00%) 
Hypoglycaemia * 1  1/181 (0.55%)  1/177 (0.56%) 
Increased appetite * 1  4/181 (2.21%)  0/177 (0.00%) 
Polydipsia * 1  1/181 (0.55%)  0/177 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/181 (1.66%)  2/177 (1.13%) 
Back pain * 1  3/181 (1.66%)  4/177 (2.26%) 
Fibromyalgia * 1  1/181 (0.55%)  1/177 (0.56%) 
Flank pain * 1  2/181 (1.10%)  0/177 (0.00%) 
Joint swelling * 1  1/181 (0.55%)  0/177 (0.00%) 
Medial tibial stress syndrome * 1  1/181 (0.55%)  0/177 (0.00%) 
Muscle spasms * 1  4/181 (2.21%)  1/177 (0.56%) 
Muscle twitching * 1  3/181 (1.66%)  0/177 (0.00%) 
Muscular weakness * 1  1/181 (0.55%)  0/177 (0.00%) 
Musculoskeletal pain * 1  1/181 (0.55%)  1/177 (0.56%) 
Myalgia * 1  0/181 (0.00%)  1/177 (0.56%) 
Neck pain * 1  1/181 (0.55%)  0/177 (0.00%) 
Osteoarthritis * 1  0/181 (0.00%)  1/177 (0.56%) 
Pain in extremity * 1  3/181 (1.66%)  3/177 (1.69%) 
Pain in jaw * 1  0/181 (0.00%)  1/177 (0.56%) 
Nervous system disorders     
Amnesia * 1  0/181 (0.00%)  1/177 (0.56%) 
Areflexia * 1  1/181 (0.55%)  0/177 (0.00%) 
Balance disorder * 1  5/181 (2.76%)  0/177 (0.00%) 
Burning sensation * 1  1/181 (0.55%)  0/177 (0.00%) 
Clumsiness * 1  2/181 (1.10%)  0/177 (0.00%) 
Cognitive disorder * 1  1/181 (0.55%)  0/177 (0.00%) 
Disturbance in attention * 1  5/181 (2.76%)  4/177 (2.26%) 
Dizziness * 1  51/181 (28.18%)  12/177 (6.78%) 
Dizziness postural * 1  1/181 (0.55%)  0/177 (0.00%) 
Dysgeusia * 1  1/181 (0.55%)  1/177 (0.56%) 
Headache * 1  14/181 (7.73%)  17/177 (9.60%) 
Hypersomnia * 1  3/181 (1.66%)  0/177 (0.00%) 
Hyporeflexia * 1  1/181 (0.55%)  0/177 (0.00%) 
Lethargy * 1  1/181 (0.55%)  1/177 (0.56%) 
Memory impairment * 1  5/181 (2.76%)  1/177 (0.56%) 
Mental impairment * 1  2/181 (1.10%)  0/177 (0.00%) 
Migraine * 1  1/181 (0.55%)  3/177 (1.69%) 
Myoclonus * 1  0/181 (0.00%)  1/177 (0.56%) 
Paraesthesia * 1  2/181 (1.10%)  1/177 (0.56%) 
Presyncope * 1  1/181 (0.55%)  0/177 (0.00%) 
Psychomotor hyperactivity * 1  1/181 (0.55%)  0/177 (0.00%) 
Repetitive speech * 1  1/181 (0.55%)  0/177 (0.00%) 
Sedation * 1  4/181 (2.21%)  2/177 (1.13%) 
Somnolence * 1  36/181 (19.89%)  8/177 (4.52%) 
Stupor * 1  1/181 (0.55%)  0/177 (0.00%) 
Tension headache * 1  1/181 (0.55%)  0/177 (0.00%) 
Psychiatric disorders     
Abnormal dreams * 1  1/181 (0.55%)  0/177 (0.00%) 
Anxiety * 1  8/181 (4.42%)  7/177 (3.95%) 
Apathy * 1  0/181 (0.00%)  1/177 (0.56%) 
Bradyphrenia * 1  2/181 (1.10%)  0/177 (0.00%) 
Confusional state * 1  2/181 (1.10%)  0/177 (0.00%) 
Depressed mood * 1  1/181 (0.55%)  2/177 (1.13%) 
Depression * 1  5/181 (2.76%)  4/177 (2.26%) 
Disorientation * 1  5/181 (2.76%)  0/177 (0.00%) 
Euphoric mood * 1  1/181 (0.55%)  0/177 (0.00%) 
Initial insomnia * 1  1/181 (0.55%)  0/177 (0.00%) 
Insomnia * 1  13/181 (7.18%)  1/177 (0.56%) 
Nervousness * 1  3/181 (1.66%)  2/177 (1.13%) 
Nightmare * 1  1/181 (0.55%)  4/177 (2.26%) 
Panic attack * 1  1/181 (0.55%)  0/177 (0.00%) 
Restlessness * 1  1/181 (0.55%)  0/177 (0.00%) 
Sleep disorder * 1  0/181 (0.00%)  1/177 (0.56%) 
Suicidal ideation * 1  2/181 (1.10%)  0/177 (0.00%) 
Thinking abnormal * 1  1/181 (0.55%)  0/177 (0.00%) 
Renal and urinary disorders     
Dysuria * 1  0/181 (0.00%)  1/177 (0.56%) 
Haematuria * 1  1/181 (0.55%)  0/177 (0.00%) 
Incontinence * 1  1/181 (0.55%)  0/177 (0.00%) 
Oliguria * 1  1/181 (0.55%)  0/177 (0.00%) 
Pollakiuria * 1  1/181 (0.55%)  1/177 (0.56%) 
Urinary retention * 1  1/181 (0.55%)  0/177 (0.00%) 
Reproductive system and breast disorders     
Dysmenorrhoea * 1  1/181 (0.55%)  0/177 (0.00%) 
Vulvovaginal dryness * 1  1/181 (0.55%)  0/177 (0.00%) 
Vulvovaginal pruritus * 1  0/181 (0.00%)  1/177 (0.56%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/181 (1.10%)  1/177 (0.56%) 
Dyspnoea * 1  1/181 (0.55%)  0/177 (0.00%) 
Epistaxis * 1  1/181 (0.55%)  0/177 (0.00%) 
Nasal congestion * 1  1/181 (0.55%)  1/177 (0.56%) 
Nasal dryness * 1  1/181 (0.55%)  0/177 (0.00%) 
Oropharyngeal pain * 1  3/181 (1.66%)  5/177 (2.82%) 
Rhinorrhoea * 1  1/181 (0.55%)  0/177 (0.00%) 
Upper-airway cough syndrome * 1  0/181 (0.00%)  1/177 (0.56%) 
Skin and subcutaneous tissue disorders     
Acne * 1  1/181 (0.55%)  0/177 (0.00%) 
Dermatitis contact * 1  1/181 (0.55%)  0/177 (0.00%) 
Hyperhidrosis * 1  0/181 (0.00%)  1/177 (0.56%) 
Night sweats * 1  2/181 (1.10%)  0/177 (0.00%) 
Pruritus * 1  4/181 (2.21%)  4/177 (2.26%) 
Pruritus generalised * 1  0/181 (0.00%)  1/177 (0.56%) 
Rash * 1  1/181 (0.55%)  3/177 (1.69%) 
Rash generalised * 1  1/181 (0.55%)  0/177 (0.00%) 
Skin lesion * 1  1/181 (0.55%)  0/177 (0.00%) 
Surgical and medical procedures     
Tooth extraction * 1  0/181 (0.00%)  1/177 (0.56%) 
Vascular disorders     
Haematoma * 1  0/181 (0.00%)  1/177 (0.56%) 
Hot flush * 1  1/181 (0.55%)  1/177 (0.56%) 
Hypertension * 1  2/181 (1.10%)  2/177 (1.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: NCT01432236     History of Changes
Other Study ID Numbers: A0081275
2011-002480-19 ( EudraCT Number )
First Submitted: September 8, 2011
First Posted: September 12, 2011
Results First Submitted: May 12, 2014
Results First Posted: October 22, 2014
Last Update Posted: October 22, 2014