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P4 (Pregabalin for Peripheral Posttraumatic Pain) (P4)

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: NCT00292188
Recruitment Status : Completed
First Posted : February 15, 2006
Results First Posted : October 5, 2009
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuralgia
Interventions Drug: pregabalin
Drug: Placebo
Enrollment 255
Recruitment Details  
Pre-assignment Details 2-week screening period and single-blind washout and placebo run-in phase followed by a 4-week randomized, dose adjustment, double-blind treatment phase
Arm/Group Title Single-Blind Placebo Double-Blind Pregabalin Double-Blind Placebo
Hide Arm/Group Description All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Period Title: Single-Blind
Started 368 0 0
Received Treatment 367 0 0
Completed 254 0 0
Not Completed 114 0 0
Reason Not Completed
Adverse Event             14             0             0
Lack of Efficacy             2             0             0
Laboratory Abnormality             5             0             0
Lost to Follow-up             3             0             0
Other             77             0             0
Withdrawal by Subject             12             0             0
Did not receive treatment             1             0             0
Period Title: Double-Blind
Started 0 127 127
Completed 0 96 98
Not Completed 0 31 29
Reason Not Completed
Adverse Event             0             25             9
Lack of Efficacy             0             2             12
Lost to Follow-up             0             1             0
Other             0             3             4
Withdrawal by Subject             0             0             3
Laboratory Abnormality             0             0             1
Arm/Group Title Pregabalin Placebo Total
Hide Arm/Group Description

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase. Total of all reporting groups
Overall Number of Baseline Participants 127 127 254
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 127 participants 254 participants
18-44 years 38 42 80
45-64 years 60 60 120
≥65 years 29 25 54
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 127 participants 254 participants
Female
77
  60.6%
52
  40.9%
129
  50.8%
Male
50
  39.4%
75
  59.1%
125
  49.2%
1.Primary Outcome
Title Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary
Hide Description Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.
Time Frame each day of Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized subjects who received >= 1 dose study drug & have post-randomization efficacy data. Last Observation Carried Forward (LOCF).
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 125
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
4.61  (0.18) 5.23  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments The study is powered to detect a clinically significant difference of 1 between treatment groups in the weekly mean pain score. Null hypothesis was that there was no difference in weekly mean pain scores between pregabalin and placebo.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline mean pain score and pooled country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval 95%
-1.09 to -0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Hide Description Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS), last observation carried forward (LOCF)
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 124 124
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
6.52  (0.29) 7.36  (0.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.84
Confidence Interval 95%
-1.60 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS) Depression Score
Hide Description Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response ("lowering of hedonic tone"). Score range = 0 to 21; higher scores indicate a greater intensity of depression
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS LOCF
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 124 124
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
5.23  (0.24) 6.20  (0.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.97
Confidence Interval 95%
-1.61 to -0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.32
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores
Hide Description Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of subjects from the FAS who had moderate/severe baseline anxiety scores. LOCF.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 32 41
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
9.94  (0.77) 11.63  (0.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.68
Confidence Interval 95%
-3.69 to 0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.00
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores
Hide Description Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of subjects from the FAS who had moderate/severe baseline depression scores. LOCF.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 17 23
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
12.04  (0.79) 11.80  (0.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.819
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval 95%
-1.87 to 2.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.03
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Weekly Mean Pain Score From Daily Pain Diary
Hide Description Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week.
Time Frame Baseline through Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 1 (n=125, 125) 5.54  (0.11) 5.79  (0.11)
Week 2 (n=121, 119) 5.37  (0.13) 5.64  (0.13)
Week 3 (n=113, 116) 4.91  (0.15) 5.44  (0.15)
Week 4 (n=108, 108) 4.95  (0.15) 5.27  (0.15)
Week 5 (n=106, 104) 4.80  (0.16) 5.26  (0.16)
Week 6 (n=104, 101) 4.76  (0.16) 5.34  (0.16)
Week 7 (n=99, 99) 4.74  (0.18) 5.26  (0.18)
Week 8 (n=97, 97) 4.64  (0.18) 5.24  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 1
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Confidence Interval 95%
-0.56 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 2: FAS
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Confidence Interval 95%
-0.62 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 3: FAS
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.53
Confidence Interval 95%
-0.93 to -0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 4: FAS
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Confidence Interval 95%
-0.74 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 5: FAS
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.46
Confidence Interval 95%
-0.90 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 6: FAS
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.59
Confidence Interval 95%
-1.03 to -0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 7: FAS
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.53
Confidence Interval 95%
-1.01 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Week 8: FAS
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Mixed Models Analysis
Comments Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.60
Confidence Interval 95%
-1.10 to -0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)
Hide Description Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a >= 30% and >=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 125
Measure Type: Number
Unit of Measure: participants
30% Responder 50 32
50% Responder 30 18
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments 30% responder
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Regression, Logistic
Comments logstic regression adjusted for treatment group, baseline pain score and pooled country.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.84
Confidence Interval 95%
1.05 to 3.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments 50% responder
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method Regression, Logistic
Comments logstic regression adjusted for treatment group, baseline pain score and pooled country.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.78
Confidence Interval 95%
0.92 to 3.46
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Weekly Mean Sleep Interference Score
Hide Description 11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 125
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
2.93  (0.17) 3.73  (0.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.79
Confidence Interval 95%
-1.25 to -0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Medical Outcome Study (MOS) Sleep Subscales
Hide Description Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. Number of subjects with evaluable data (n = pregabalin, placebo), respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Sleep Disturbance (n=117, 118) 35.73  (1.96) 46.45  (1.94)
Snoring (n=111, 118) 38.92  (2.04) 37.87  (1.97)
Awaken Short of Breath/Headache (n= 118, 117) 14.71  (2.14) 20.66  (2.13)
Sleep Quantity (n=117, 118) 6.39  (0.32) 6.48  (0.32)
Sleep Adequacy (n=119, 119) 55.25  (2.44) 44.61  (2.43)
Somnolence (n=116, 114) 34.64  (1.75) 32.33  (1.77)
Sleep Problems Index-6 (n=112, 111) 42.20  (1.96) 51.72  (1.97)
Sleep problems Index-9 (n=111, 107) 35.43  (1.49) 42.98  (1.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Sleep Disturbance
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.72
Confidence Interval 95%
-15.89 to -5.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Snoring
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.700
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.05
Confidence Interval 95%
-4.30 to 6.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Awaken Short of Breath/Headache
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.95
Confidence Interval 95%
-11.62 to -0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Sleep Quantity
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.846
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval 95%
-0.92 to 0.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Sleep Adequacy
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.63
Confidence Interval 95%
4.19 to 17.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Somnolence
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.324
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.31
Confidence Interval 95%
-2.30 to 6.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Sleep Problems Index-6
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.52
Confidence Interval 95%
-14.71 to -4.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Sleep Problems Index-9
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.54
Confidence Interval 95%
-11.52 to -3.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.02
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Medical Outcome Study (MOS) Optimal Sleep
Hide Description Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 117 119
Measure Type: Number
Unit of Measure: participants
58 45
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.267
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression adjusted for treatment group, baseline score and pooled country.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.42
Confidence Interval 95%
0.76 to 2.64
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Patient Global Impression of Change (PGIC)
Hide Description Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient's overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Measure Type: Number
Unit of Measure: participants
very much improved 13 6
much improved 27 22
minimally improved 41 26
no change 30 52
minimally worse 3 10
much worse 3 7
very much worse 3 2
12.Secondary Outcome
Title Clinical Global Impression of Change (CGIC)
Hide Description Clinical Global Impression of Change (CGIC): clinician's judgment of overall change in the patient's condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Measure Type: Number
Unit of Measure: participants
very much improved 11 6
much improved 33 18
minimally improved 36 26
no change 33 61
minimally worse 5 9
much worse 4 3
very much worse 1 1
13.Secondary Outcome
Title Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
Hide Description Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time Frame Screening, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 127 127
Mean (Standard Deviation)
Unit of Measure: score on a scale
Screening (n=113, 113) 54.53  (27.60) 53.60  (26.07)
End of Treatment (Week 8) (n=122, 121) 52.64  (31.87) 42.56  (32.52)
14.Secondary Outcome
Title Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Hide Description Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time Frame Screening, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 122 121
Mean (Standard Deviation)
Unit of Measure: score on scale
Screening (n=112, 110) 50.33  (20.85) 51.05  (20.52)
Week 8 (n=122, 121) 62.36  (22.22) 54.15  (22.78)
15.Secondary Outcome
Title Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics
Hide Description Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time Frame Screening, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 127 127
Mean (Standard Deviation)
Unit of Measure: score on scale
Screening (n=112, 110) 57.44  (21.84) 59.39  (22.21)
End of Treatment (Week 8) (n=122, 121) 71.52  (19.58) 70.39  (21.00)
16.Secondary Outcome
Title Pain Treatment Satisfaction Scale (PTSS): Efficacy
Hide Description Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time Frame Screening, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 127 127
Mean (Standard Deviation)
Unit of Measure: score on scale
Screening (n=112, 110) 43.23  (24.06) 42.73  (23.98)
End of Treatment (Week 8) (n=122, 121) 53.21  (30.63) 37.88  (32.61)
17.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf)
Hide Description Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline; FAS, LOCF. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Mean (Standard Deviation)
Unit of Measure: score on a scale
pain interference index Baseline (n=125, 126) 4.57  (2.11) 4.69  (2.36)
pain interference index Week 8 (n=120, 121) 3.31  (2.41) 4.17  (2.49)
pain severity index Baseline (n= 122, 125) 5.36  (1.71) 5.72  (2.04)
pain severity index Week 8 (n=120, 120) 4.20  (2.35) 5.21  (2.42)
18.Secondary Outcome
Title Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score
Hide Description Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of subjects with a non-missing NPSI Total Intensity Score at Baseline and Week 8 (using LOCF) is 100, 106 for pregabalin, placebo respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Least Squares Mean (Standard Error)
Unit of Measure: percentage score on scale
33.29  (1.68) 37.12  (1.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.84
Confidence Interval 95%
-8.28 to 0.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.25
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Hide Description The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Measure Type: Number
Unit of Measure: participants
Baseline: All of the Time 5 1
Baseline: Most of the Time 6 15
Baseline: A Good Bit of the Time 5 15
Baseline: Some of the Time 20 25
Baseline: A Little of the Time 42 27
Baseline: None of the Time 48 43
Week 8: All of the Time 3 4
Week 8: Most of the Time 10 5
Week 8: A Good Bit of the Time 11 13
Week 8: Some of the Time 23 27
Week 8: A Little of the Time 32 30
Week 8: None of the Time 41 42
20.Secondary Outcome
Title Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Hide Description The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Measure Type: Number
Unit of Measure: participants
Baseline: All of the Time 4 4
Baseline: Most of the Time 8 14
Baseline: A Good Bit of the Time 13 14
Baseline: Some of the Time 27 29
Baseline: A Little of the Time 33 26
Baseline: None of the Time 41 39
Week 8: All of the Time 3 7
Week 8: Most of the Time 12 5
Week 8: A Good Bit of the Time 14 16
Week 8: Some of the Time 26 27
Week 8: A Little of the Time 27 33
Week 8: None of the Time 38 33
21.Secondary Outcome
Title Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Hide Description The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. The number of subjects that answered the question at Week 8 is 119, 121 for pregabalin, placebo respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Measure Type: Number
Unit of Measure: particpants
Baseline: All of the Time 2 6
Baseline: Most of the Time 8 12
Baseline: A Good Bit of the Time 6 7
Baseline: Some of the Time 22 15
Baseline: A Little of the Time 23 35
Baseline: None of the Time 64 51
Week 8: All of the Time 1 3
Week 8: Most of the Time 9 11
Week 8: A Good Bit of the Time 9 6
Week 8: Some of the Time 26 23
Week 8: A Little of the Time 22 27
Week 8: None of the Time 52 51
22.Secondary Outcome
Title Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Hide Description The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Measure Type: Number
Unit of Measure: participants
Baseline: All of the Time 7 10
Baseline: Most of the Time 7 14
Baseline: A Good Bit of the Time 6 8
Baseline: Some of the Time 40 23
Baseline: A Little of the Time 30 33
Baseline: None of the Time 36 38
Week 8: All of the Time 3 9
Week 8: Most of the Time 11 7
Week 8: A Good Bit of Time 13 11
Week 8: Some of the Time 28 31
Week 8: A Little of the Time 36 35
Week 8: None of the Time 29 28
23.Secondary Outcome
Title Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Hide Description The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Measure Type: Number
Unit of Measure: participants
Baseline: All of the Time 5 3
Baseline: Most of the Time 3 16
Baseline: A Good Bit of Time 13 14
Baseline: Some of the Time 24 23
Baseline: A Little of the Time 39 23
Baseline: None of the Time 42 47
Week 8: All of the Time 4 5
Week 8: Most of the Time 10 7
Week 8: A Good Bit of Time 8 13
Week 8: Some of the Time 22 26
Week 8: A Little of the Time 34 34
Week 8: None of the Time 42 36
24.Secondary Outcome
Title Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Hide Description The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Measure Type: Number
Unit of Measure: participants
Baseline: All of the Time 2 1
Baseline: Most of the Time 6 9
Baseline: A Good Bit of Time 3 6
Baseline: Some of the Time 31 27
Baseline: A Little of the Time 33 36
Baseline: None of the Time 51 45
Week 8: All of the Time 4 6
Week 8: Most of the Time 6 9
Week 8: A Good Bit of Time 12 6
Week 8: Some of the Time 28 22
Week 8: A Little of the Time 31 31
Week 8: None of the Time 39 47
25.Secondary Outcome
Title Davidson Trauma Scale (DTS): Severity
Hide Description Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (n=116, 118) 15.55  (14.16) 17.83  (16.94)
Week 8 (n=112, 113) 11.71  (13.77) 15.43  (16.91)
26.Secondary Outcome
Title Davidson Trauma Scale (DTS): Frequency
Hide Description Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n=124, 124) 18.27  (13.98) 20.90  (15.11)
Week 8 (n=118, 120) 14.16  (12.67) 18.47  (15.51)
27.Secondary Outcome
Title Davidson Trauma Scale (DTS): Total Score
Hide Description Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
Overall Number of Participants Analyzed 126 126
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline (n=116, 118) 34.57  (27.56) 38.76  (31.55)
Week 8 (n=112, 113) 26.18  (26.09) 33.62  (31.65)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single-Blind Placebo Double-Blind Pregabalin Double-Blind Placebo
Hide Arm/Group Description All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.

Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).

At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day).

Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
All-Cause Mortality
Single-Blind Placebo Double-Blind Pregabalin Double-Blind Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Single-Blind Placebo Double-Blind Pregabalin Double-Blind Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2   4   2 
Infections and infestations       
Viral infection  2  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Injury, poisoning and procedural complications       
Fall  2  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Skin laceration  2  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Foot fracture  2  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Accidental Over Dose  3  1/367 (0.27%)  0/127 (0.00%)  1/127 (0.79%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Muscle spasm  2  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Nervous system disorders       
Tremor  2  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Psychiatric disorders       
Confusional state  2  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v12.0)
2
Term from vocabulary, MedDRA (12.0)
3
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single-Blind Placebo Double-Blind Pregabalin Double-Blind Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   77   109   73 
Blood and lymphatic system disorders       
Leukopenia  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Thrombocytopenia  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Cardiac disorders       
Palpitations  1  1/367 (0.27%)  0/127 (0.00%)  0/127 (0.00%) 
Ear and labyrinth disorders       
Hypoacusis  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Vertigo  1  0/367 (0.00%)  4/127 (3.15%)  1/127 (0.79%) 
Endocrine disorders       
Goitre  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Hyperthyroidism  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Hypothyroidism  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Thyroid disorder  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Eye disorders       
Abnormal sensation in eye  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Altered visual depth perception  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Blepharospasm  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Diplopia  1  1/367 (0.27%)  0/127 (0.00%)  0/127 (0.00%) 
Vision blurred  1  3/367 (0.82%)  8/127 (6.30%)  3/127 (2.36%) 
Visual acuity reduced  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Gastrointestinal disorders       
Abdominal discomfort  1  1/367 (0.27%)  1/127 (0.79%)  1/127 (0.79%) 
Abdominal pain upper  1  1/367 (0.27%)  2/127 (1.57%)  2/127 (1.57%) 
Constipation  1  1/367 (0.27%)  9/127 (7.09%)  4/127 (3.15%) 
Diarrhoea  1  5/367 (1.36%)  5/127 (3.94%)  5/127 (3.94%) 
Dry mouth  1  5/367 (1.36%)  14/127 (11.02%)  6/127 (4.72%) 
Dyspepsia  1  2/367 (0.54%)  2/127 (1.57%)  0/127 (0.00%) 
Flatulence  1  1/367 (0.27%)  2/127 (1.57%)  0/127 (0.00%) 
Frequent bowel movements  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Gastric disorder  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Gastritis  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Haemorrhoids  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Hyperchlorhydria  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Hypoaesthesia oral  1  0/367 (0.00%)  0/127 (0.00%)  2/127 (1.57%) 
Irritable bowel syndrome  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Nausea  1  8/367 (2.18%)  12/127 (9.45%)  8/127 (6.30%) 
Toothache  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Vomiting  1  1/367 (0.27%)  4/127 (3.15%)  2/127 (1.57%) 
Adominal pain  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
General disorders       
Asthenia  1  0/367 (0.00%)  2/127 (1.57%)  0/127 (0.00%) 
Chest discomfort  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Chest pain  1  3/367 (0.82%)  0/127 (0.00%)  0/127 (0.00%) 
Fatigue  1  4/367 (1.09%)  15/127 (11.81%)  10/127 (7.87%) 
Feeling abnormal  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Feeling drunk  1  0/367 (0.00%)  5/127 (3.94%)  0/127 (0.00%) 
Feeling hot  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Feeling jittery  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Gait disturbance  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Hunger  1  1/367 (0.27%)  0/127 (0.00%)  0/127 (0.00%) 
Influenza like illness  1  1/367 (0.27%)  0/127 (0.00%)  0/127 (0.00%) 
Irritatibility  1  0/367 (0.00%)  0/127 (0.00%)  2/127 (1.57%) 
Localised oedema  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Malaise  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Mucosal dryness  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Oedema peripheral  1  1/367 (0.27%)  9/127 (7.09%)  3/127 (2.36%) 
Pain  1  3/367 (0.82%)  5/127 (3.94%)  0/127 (0.00%) 
Thirst  1  0/367 (0.00%)  2/127 (1.57%)  2/127 (1.57%) 
Immune system disorders       
Hypersensitivity  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Infections and infestations       
Bronchitis  1  0/367 (0.00%)  2/127 (1.57%)  0/127 (0.00%) 
Cystitis  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Gastroenteritis  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Herpes simplex  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Herpes zoster  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Infulenza  1  2/367 (0.54%)  3/127 (2.36%)  2/127 (1.57%) 
Lower respiratory tract infection  1  0/367 (0.00%)  2/127 (1.57%)  0/127 (0.00%) 
Lung infection  1  1/367 (0.27%)  0/127 (0.00%)  0/127 (0.00%) 
Nasopharyngitis  1  2/367 (0.54%)  1/127 (0.79%)  3/127 (2.36%) 
Pharyngitis  1  1/367 (0.27%)  2/127 (1.57%)  0/127 (0.00%) 
Pneumonia  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Respiratory tract infection  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Schistomosomiasis cutaneous  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Sinusitis  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Skin infection  1  1/367 (0.27%)  0/127 (0.00%)  1/127 (0.79%) 
Tooth infection  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Upper respiratory tract infection  1  0/367 (0.00%)  3/127 (2.36%)  0/127 (0.00%) 
Urinary tract infection  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Viral infection  1  1/367 (0.27%)  0/127 (0.00%)  1/127 (0.79%) 
Viral upper respiratory tract infection  1  0/367 (0.00%)  1/127 (0.79%)  1/127 (0.79%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Arthropod bite  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Fall  1  1/367 (0.27%)  2/127 (1.57%)  3/127 (2.36%) 
Joint sprain  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Muscle strain  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Skeletal injury  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Skin laceration  1  0/367 (0.00%)  2/127 (1.57%)  0/127 (0.00%) 
Investigations       
Blood calcium increased  2  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Blood cholesterol increased  2  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Blood glucose increased  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Blood pressure systolic increased  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Blood thyroid stimulating hormone increased  1  0/367 (0.00%)  1/127 (0.79%)  1/127 (0.79%) 
Blood triglycerides decreased  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Blood triglycerides increased  1  0/367 (0.00%)  0/127 (0.00%)  2/127 (1.57%) 
Creatinine renal clearance decreased  1  2/367 (0.54%)  0/127 (0.00%)  0/127 (0.00%) 
Drug screen positive  1  1/367 (0.27%)  0/127 (0.00%)  0/127 (0.00%) 
Haemoglobin increased  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Neutrophil count increased  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Wieght increased  1  1/367 (0.27%)  5/127 (3.94%)  2/127 (1.57%) 
Blood calcium decreased  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Metabolism and nutrition disorders       
Fluid retention  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Hypercholesterolaemia  1  0/367 (0.00%)  1/127 (0.79%)  1/127 (0.79%) 
Increased appetite  1  2/367 (0.54%)  2/127 (1.57%)  3/127 (2.36%) 
Polydipsia  1  1/367 (0.27%)  0/127 (0.00%)  0/127 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/367 (0.27%)  3/127 (2.36%)  2/127 (1.57%) 
Arthritis  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Arthropathy  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Back pain  1  2/367 (0.54%)  1/127 (0.79%)  2/127 (1.57%) 
Inguinal mass  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Joint swelling  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Muscle spasms  1  1/367 (0.27%)  1/127 (0.79%)  1/127 (0.79%) 
Muscle tightness  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Muscular weakness  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Musculoskeletal chest pain  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Musculoskeletal pain  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Musculoskeletal stiffness  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Myalgia  1  1/367 (0.27%)  0/127 (0.00%)  1/127 (0.79%) 
Neck pain  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Pain in extremity  1  1/367 (0.27%)  1/127 (0.79%)  2/127 (1.57%) 
Nervous system disorders       
Ataxia  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Balance disorder  1  0/367 (0.00%)  4/127 (3.15%)  0/127 (0.00%) 
Coordination abnormal  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Crying  1  1/367 (0.27%)  0/127 (0.00%)  0/127 (0.00%) 
Disturbance in attention  1  1/367 (0.27%)  9/127 (7.09%)  4/127 (3.15%) 
Dizziness  1  10/367 (2.72%)  55/127 (43.31%)  12/127 (9.45%) 
Dysaesthesia  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Dysarthria  1  0/367 (0.00%)  2/127 (1.57%)  0/127 (0.00%) 
Dyskinesia  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Formication  1  1/367 (0.27%)  1/127 (0.79%)  1/127 (0.79%) 
Head discomfort  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Headache  1  14/367 (3.81%)  15/127 (11.81%)  14/127 (11.02%) 
Hypoaesthesia  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Memory impairment  1  0/367 (0.00%)  4/127 (3.15%)  3/127 (2.36%) 
Mental impairment  1  0/367 (0.00%)  2/127 (1.57%)  0/127 (0.00%) 
Migraine  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Neuralgia  1  1/367 (0.27%)  5/127 (3.94%)  2/127 (1.57%) 
Paraesthesia  1  2/367 (0.54%)  3/127 (2.36%)  0/127 (0.00%) 
Sciatica  1  1/367 (0.27%)  2/127 (1.57%)  0/127 (0.00%) 
Somnolence  1  3/367 (0.82%)  20/127 (15.75%)  8/127 (6.30%) 
Speech disorder  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Syncope  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Tension headache  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Tremor  1  0/367 (0.00%)  1/127 (0.79%)  1/127 (0.79%) 
Psychiatric disorders       
Abnormal dreams  1  0/367 (0.00%)  2/127 (1.57%)  0/127 (0.00%) 
Agitation  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Anxiety  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Daydreaming  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Deja vu  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Depression  1  2/367 (0.54%)  1/127 (0.79%)  0/127 (0.00%) 
Disinhibition  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Disorientation  1  0/367 (0.00%)  2/127 (1.57%)  0/127 (0.00%) 
Dissociation  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Dyssomnia  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Emotional disorder  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Encopresis  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Euphoric  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Insomnia  1  1/367 (0.27%)  1/127 (0.79%)  6/127 (4.72%) 
Libido decreased  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Mood altered  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Morose  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Nervousness  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Nightmare  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Restlessness  1  0/367 (0.00%)  1/127 (0.79%)  1/127 (0.79%) 
Sleep disorder  1  0/367 (0.00%)  0/127 (0.00%)  2/127 (1.57%) 
Tic  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Renal and urinary disorders       
Haematuria  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Polyuria  1  2/367 (0.54%)  1/127 (0.79%)  0/127 (0.00%) 
Urinary retention  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Reproductive system and breast disorders       
Dysmenorrhoea  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Sexual dysfunction  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Dysphonia  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Dysponea  1  0/367 (0.00%)  1/127 (0.79%)  2/127 (1.57%) 
Nasal dryness  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Oropharyngeal  1  0/367 (0.00%)  1/127 (0.79%)  1/127 (0.79%) 
Pleurisy  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Sinus congestion  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  1/367 (0.27%)  1/127 (0.79%)  0/127 (0.00%) 
Acne  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Dermatitis  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Dry skin  1  0/367 (0.00%)  3/127 (2.36%)  1/127 (0.79%) 
Erythema  1  0/367 (0.00%)  2/127 (1.57%)  0/127 (0.00%) 
Hyperhidrosis  1  0/367 (0.00%)  4/127 (3.15%)  1/127 (0.79%) 
Ingrowing nail  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Night sweats  1  1/367 (0.27%)  0/127 (0.00%)  2/127 (1.57%) 
Rash  1  0/367 (0.00%)  1/127 (0.79%)  2/127 (1.57%) 
Rash pruritic  1  0/367 (0.00%)  0/127 (0.00%)  2/127 (1.57%) 
Skin discolouration  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Surgical and medical procedures       
Breast prothesis implantation  1  0/367 (0.00%)  0/127 (0.00%)  1/127 (0.79%) 
Vascular disorders       
Hot flush  1  1/367 (0.27%)  0/127 (0.00%)  0/127 (0.00%) 
Hypertension  1  1/367 (0.27%)  5/127 (3.94%)  2/127 (1.57%) 
Hypotension  1  1/367 (0.27%)  1/127 (0.79%)  2/127 (1.57%) 
Thrombophlebitis superficial  1  0/367 (0.00%)  1/127 (0.79%)  0/127 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v12.0)
2
Term from vocabulary, MedDRA (12.0)
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 < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
ClinicalTrials.gov Identifier: NCT00292188    
Other Study ID Numbers: A0081064
First Submitted: February 13, 2006
First Posted: February 15, 2006
Results First Submitted: May 27, 2009
Results First Posted: October 5, 2009
Last Update Posted: February 9, 2021