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Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP

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ClinicalTrials.gov Identifier: NCT00407511
Recruitment Status : Completed
First Posted : December 5, 2006
Results First Posted : August 19, 2009
Last Update Posted : October 15, 2009
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetic Peripheral Neuropathic Pain (DPN)
Postherpetic Neuralgia (PHN)
HIV-related Neuropathic Pain (HIV)
Chemotherapy Induced Neuropathic Pain
Intervention Drug: Pregabalin
Enrollment 121
Recruitment Details Subjects were recruited at 13 medical centers in Latin America and participated between January 2007 and July 2008.
Pre-assignment Details 160 subjects were screened and evaluated for inclusion/exclusion criteria; 121 were assigned to open-label treatment.
Arm/Group Title Pregabalin
Hide Arm/Group Description Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Period Title: Overall Study
Started 121
Completed 99
Not Completed 22
Reason Not Completed
Adverse Event             9
Lost to Follow-up             4
Other             5
Withdrawal by Subject             4
Arm/Group Title Pregabalin
Hide Arm/Group Description Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Baseline Participants 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants
Between 18 to 44 years 15
Between 45 to 64 years 76
>= 65 years 30
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants
Female
83
  68.6%
Male
38
  31.4%
1.Primary Outcome
Title Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Hide Description 11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.
Time Frame Baseline, End of Treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF).
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: scores on scale
-3.8  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments End of treatment/last observation carried forward (EOT/LOCF): value consists of the mean of the last 7 post-baseline visits scores. Mean change: the arithmetic mean change and p-value from the single sample t-test. If < = 7 and > = 4 post-baseline scores were available, the mean pain score was computed using the available scores. The mean was not calculated if there were less than 4 post-baseline scores prior to study termination.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Hide Description 11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.
Time Frame Week 4, Week 8, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 4 (n=110) -3.2  (1.9)
Week 8 (n=100) -3.9  (2.3)
Week 12 (n=96) -4.2  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval 95%
-3.6 to -2.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.9
Confidence Interval 95%
-4.3 to -3.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.1
Confidence Interval 95%
-4.5 to -3.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
3.Secondary Outcome
Title Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
Hide Description Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.
Time Frame Baseline, Week 8, Week 12, EOT/LOCF
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 8 (n=102) -4.2  (2.6)
Week 12 (n=98) -4.7  (2.6)
EOT/LOCF (n=102) -4.6  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 8, FAS. Week 8: subjects were only included if their visit fell within the computed week (49 to 63 days).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.2
Confidence Interval 95%
-4.7 to -3.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 12: subjects were only included if their visit fell within the computed week (>= 78 days).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.6
Confidence Interval 95%
-5.1 to -4.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores
Hide Description Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.
Time Frame Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 8 (n=102) -3.8  (2.7)
Week 12 (n=98) -4.2  (2.6)
EOT/LOCF (n=102) -4.0  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 8: subjects were only included if their visit fell within the computed week (Day 49 to 63).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.8
Confidence Interval 95%
-4.2 to -3.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 12: subjects were only included if their visit fell within the computed week (>= Day 78)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.1
Confidence Interval 95%
-4.5 to -3.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
Hide Description Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.
Time Frame Baseline, Week 8, Week 12, EOT/LOCF
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: scores on scale
Baseline (n=78) 62.34  (29.99)
Week 8 (n=100) 90.38  (16.17)
Week 12 (n=97) 91.66  (13.83)
EOT/LOCF (n=105) 91.40  (14.95)
6.Secondary Outcome
Title Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Hide Description Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.
Time Frame Baseline, Week 8, Week 12, EOT/LOCF
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: scores on scale
Baseline (n=78) 52.56  (24.68)
Week 8 (n=100) 85.92  (16.96)
Week 12 (n=97) 88.56  (13.87)
EOT/LOCF (n=105) 88.08  (14.72)
7.Secondary Outcome
Title Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)
Hide Description 100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 1 (n = 120) -18.8  (21.9)
Week 2 (n = 116) -28.5  (24.1)
Week 3 (n = 116) -34.9  (25.8)
Week 4 (n = 109) -41.0  (24.6)
Week 8 (n = 102) -46.6  (26.2)
Week 12 (n = 98) -49.0  (26.6)
EOT/LOCF (n = 120) -45.9  (28.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 1: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 1 assessment if their visit fell within Days 4 to 10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.1
Confidence Interval 95%
-22.3 to -14.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.1
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 2: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 2 assessment if their visit fell within Days 11 to 17.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -28.2
Confidence Interval 95%
-32.4 to -24.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.1
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 3: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 3 assessment if their visit fell within Days 18 to 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -34.3
Confidence Interval 95%
-38.5 to -30.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.1
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 4: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 4 assessment if their visit fell within days 25 to 35.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -40.9
Confidence Interval 95%
-45.2 to -36.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 8: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 8 assessment if their visit fell within Days 49 to 63.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -45.8
Confidence Interval 95%
-50.2 to -41.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 12: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 12 assessment if their visit fell >= Day 78.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -48.4
Confidence Interval 95%
-52.8 to -44.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments EOT/LOCF: last post-baseline assessment. Mean change is the arithmetic mean change; p-value is from a single-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)
Hide Description 100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.
Time Frame Baseline, Week 8, Week 12, EOT/LOCF
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 118
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 8 (n=99) -39.2  (29.6)
Week 12 (n=97) -41.4  (32.9)
EOT/LOCF (n=101) -40.5  (33.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 8: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 8 assessment only if their visit fell within Days 49 and 63.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -38.7
Confidence Interval 95%
-43.4 to -33.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.4
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 12: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 12 assessment only if their visit fell >=Day 78.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -40.7
Confidence Interval 95%
-45.5 to -35.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.4
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments EOT/LOCF: last post-baseline assessment. Mean change= arithmetic mean change; p-value is from a single-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Mean Daily Sleep Interference Score (DSIS)
Hide Description Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 1 (n=120) -1.0  (1.5)
Week 2 (n=118) -1.8  (2.0)
Week 3 (n=114) -2.5  (2.2)
Week 4 (n=110) -2.8  (2.3)
Week 5 (n=104 -3.0  (2.3)
Week 6 (n=103) -3.1  (2.5)
Week 7 (n=100) -3.3  (2.5)
Week 8 (n=100) -3.4  (2.5)
Week 9 (n=97) -3.5  (2.6)
Week 10 (n=99) -3.5  (2.7)
Week 11 (n=98) -3.5  (2.6)
Week 12 (n=96) -3.4  (2.7)
EOT/LOCF (n=120) -3.1  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 1: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval 95%
-1.4 to -0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 2: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval 95%
-2.2 to -1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 3: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Confidence Interval 95%
-2.9 to -2.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 4: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.8
Confidence Interval 95%
-3.2 to -2.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 5: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.9
Confidence Interval 95%
-3.3 to -2.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 6: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.0
Confidence Interval 95%
-3.4 to -2.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 7: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.1
Confidence Interval 95%
-3.5 to -2.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 8: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval 95%
-3.6 to -2.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 9: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.3
Confidence Interval 95%
-3.7 to -2.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 10: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.4
Confidence Interval 95%
-3.7 to -3.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Visit 11: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.4
Confidence Interval 95%
-3.8 to -3.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments Week 12: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.4
Confidence Interval 95%
-3.7 to -3.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Parameter estimate: Mean Difference (Final Values) = least squares mean.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pregabalin
Comments EOT/LOCF value consists of the mean of the last 7 post-baseline sleep scores; mean change = arithmetic mean change; p-value: from single sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Patient Global Impression of Change (PGIC)
Hide Description 7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)
Time Frame End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: participants
Very much improved 37
Much improved 53
Minimally improved 12
No change 1
Minimally worse 0
Much worse 0
Very much worse 0
11.Secondary Outcome
Title Clinical Global Impression of Change (CGIC)
Hide Description 7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).
Time Frame End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: participants
Very much improved 41
Much improved 55
Minimally improved 5
No change 2
Minimally worse 0
Much Worse 0
Very much worse 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin
Hide Arm/Group Description Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
All-Cause Mortality
Pregabalin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin
Affected / at Risk (%)
Total   4 
Cardiac disorders   
Cardiac failure * 1  1/121 (0.83%) 
Pericarditis *  1/121 (0.83%) 
Eye disorders   
Vitreous haemorrhage *  1/121 (0.83%) 
General disorders   
Generalized oedema *  1/121 (0.83%) 
Musculoskeletal and connective tissue disorders   
Neuropathic arthropathy *  1/121 (0.83%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to central nervous system *  1/121 (0.83%) 
Nervous system disorders   
Headache *  1/121 (0.83%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (v12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin
Affected / at Risk (%)
Total   69 
Gastrointestinal disorders   
Dry mouth  1  8/121 (6.61%) 
Nausea   6/121 (4.96%) 
General disorders   
Oedema   7/121 (5.79%) 
Oedema peripheral   14/121 (11.57%) 
Investigations   
Weight increased   15/121 (12.40%) 
Metabolism and nutrition disorders   
Increased appetite   7/121 (5.79%) 
Nervous system disorders   
Dizziness   25/121 (20.66%) 
Headache   8/121 (6.61%) 
Somnolence   38/121 (31.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v12.0)
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
Name/Title: Pfizer Clinical Trials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer Inc.
ClinicalTrials.gov Identifier: NCT00407511     History of Changes
Other Study ID Numbers: A0081097
First Submitted: December 1, 2006
First Posted: December 5, 2006
Results First Submitted: June 18, 2009
Results First Posted: August 19, 2009
Last Update Posted: October 15, 2009