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Pregabalin Trial In HIV Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01145417
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : June 16, 2010
Results First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV-1 Infection
Neuropathic Pain
Intervention Drug: pregabalin (Lyrica)
Enrollment 217
Recruitment Details Following completion of Visit 9 (Day 57) of double-blind trial A0081244 (NCT01049217), participants who met eligibility criteria initiated open-label treatment in the current trial A0081251 (NCT01145417).
Pre-assignment Details  
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period. Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Period Title: Overall Study
Started 108 109
Completed 67 62
Not Completed 41 47
Reason Not Completed
Death             1             0
Lost to Follow-up             2             1
Withdrawal by Subject             1             2
Pregnancy             1             0
Adverse Event             0             1
Study terminated by sponsor             35             43
Other             1             0
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin Total
Hide Arm/Group Description Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period. Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period. Total of all reporting groups
Overall Number of Baseline Participants 108 109 217
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 109 participants 217 participants
42.4  (8.8) 43.5  (7.9) 42.9  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 109 participants 217 participants
Female
71
  65.7%
68
  62.4%
139
  64.1%
Male
37
  34.3%
41
  37.6%
78
  35.9%
1.Primary Outcome
Title Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline up to 30 days after last dose of study treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population (SAF) included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description:
Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: participants
AEs 67 70
SAEs 4 3
2.Secondary Outcome
Title Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Hide Description WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a Human Immunodeficiency Virus (HIV) neuropathy pain. Number of participants who responded “Yes/No” to Question 1: Are you currently employed (working for pay)? are reported.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for each arm group, respectively.
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description:
Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
Baseline, employed (n=52,51) 12 11
Baseline, unemployed (n=52,51) 40 40
Week 24, employed (n=103,104) 35 27
Week 24, unemployed (n=103,104) 68 77
3.Secondary Outcome
Title Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Hide Description WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific question for each arm group, respectively.
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description:
Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Number of Participants Analyzed 35 28
Mean (Standard Deviation)
Unit of Measure: hours
Baseline, hours missed,leg/foot pain (n=12,11) 2.25  (6.877) 0.82  (2.401)
Baseline, hours missed,other reason (n=12,11) 3.42  (6.501) 0.91  (1.700)
Baseline, hours worked (n=12,11) 35.58  (15.163) 30.36  (18.112)
Week 24, hours missed,leg/foot pain (n=35,28) 2.17  (4.956) 2.32  (8.533)
Week 24, hours missed,other reason (n=35,28) 9.20  (21.604) 7.71  (14.976)
Week 24, hours worked (n=35,28) 41.51  (20.034) 34.86  (21.329)
4.Secondary Outcome
Title Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Hide Description WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific question for each arm group, respectively.
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description:
Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Number of Participants Analyzed 103 104
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline, productivity affected (n=12,10) 4.42  (2.843) 2.40  (2.716)
Baseline, daily activity affected (n=52,51) 3.48  (2.846) 3.47  (2.935)
Week 24, productivity affected (n=35,29) 2.17  (1.917) 2.24  (2.415)
Week 24, daily activity affected (n=103,104) 2.51  (2.330) 2.72  (2.653)
5.Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36)
Hide Description SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who took at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific parameter for each arm group, respectively.
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description:
Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Number of Participants Analyzed 103 104
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: Ph Fn (n=51,53) 73.14  (22.671) 75.47  (22.729)
Baseline: R-P (n=51,53) 75.49  (22.873) 71.93  (27.616)
Baseline: BP (n=51,53) 68.86  (20.430) 68.87  (26.010)
Baseline: GH (n=51,53) 72.25  (20.369) 68.79  (20.411)
Baseline: Ph C (n=51,53) 47.68  (7.268) 46.85  (9.578)
Baseline: Vit (n=51,53) 71.57  (19.418) 73.11  (17.660)
Baseline: So Fn (n=51,53) 78.92  (18.113) 82.08  (18.911)
Baseline: R-E (n=51,53) 81.05  (20.075) 79.87  (23.367)
Baseline: MnH (n=51,53) 76.27  (18.079) 80.00  (15.411)
Baseline: Mn C (n=51,53) 51.41  (8.915) 52.71  (7.763)
Week 24: Ph Fn (n=103,104) 70.34  (27.594) 75.24  (25.086)
Week 24: R-P (n=103,104) 71.18  (24.927) 72.96  (26.680)
Week 24: BP (n=102,104) 69.57  (22.550) 72.19  (23.033)
Week 24: GH (n=103,104) 73.14  (19.933) 71.31  (19.879)
Week 24: Ph C (n=102,104) 47.28  (8.770) 48.48  (8.634)
Week 24: Vit (n=103,104) 68.51  (18.502) 66.29  (20.039)
Week 24: So Fn (n=103,104) 79.98  (20.883) 81.85  (20.304)
Week 24: R-E (n=103,104) 74.19  (27.029) 75.80  (25.640)
Week 24: MnH (n=103,104) 76.21  (18.196) 75.77  (18.588)
Week 24: Mn C (n=102,104) 50.15  (10.394) 49.72  (9.884)
6.Secondary Outcome
Title Visual Analogue Scale for Pain (VAS-pain)
Hide Description Participants rated the severity of HIV neuropathy pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Week 4, 8, 12, 16, 20, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description:
Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Number of Participants Analyzed 107 108
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
Baseline (n=107,108) 40.6  (26.55) 40.7  (26.57)
Week 4 (n=106,106) 33.1  (25.14) 33.1  (27.11)
Week 8 (n=100,101) 27.4  (21.01) 27.8  (24.25)
Week 12 (n=89,88) 24.1  (22.41) 23.8  (23.45)
Week 16 (n=85,81) 22.6  (20.82) 22.6  (25.32)
Week 20 (n=72,67) 17.2  (19.18) 17.7  (22.78)
Week 24 (n=103,104) 22.2  (22.54) 23.7  (23.94)
7.Secondary Outcome
Title Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Hide Description PGI-C: participant rated instrument to measure participant's change in overall status since the start of the study, on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description:
Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: participants
Very Much Improved 41 37
Much Improved 43 47
Minimally Improved 16 16
No Change 2 3
Minimally Worse 1 0
Much Worse 0 1
Very Much Worse 0 0
8.Secondary Outcome
Title Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Hide Description S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.
Time Frame Baseline up to Week 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
SAF included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description:
Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Number of Participants Analyzed 108 109
Measure Type: Number
Unit of Measure: participants
Suicide attempt: 2 0 1
Preparatory acts toward suicidal behavior: 3 0 1
Suicidal ideation: 4 4 9
9.Secondary Outcome
Title Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Hide Description PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated “Over past 2 weeks, how often bothered by any of following problems?”: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual(8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
SAF population included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description:
Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Number of Participants Analyzed 107 108
Measure Type: Number
Unit of Measure: participants
Little interest in things: Not at All 59 67
Little interest in things: Several Days 31 25
Little interest in things: More Than Half the Days 14 9
Little interest in things: Nearly Every Day 3 7
Feeling down: Not at All 84 79
Feeling down: Several Days 18 21
Feeling down: More Than Half the Days 5 6
Feeling down: Nearly Every Day 0 2
Trouble with sleep: Not at All 57 59
Trouble with sleep: Several Days 33 40
Trouble with sleep: More Than Half the Days 14 4
Trouble with sleep: Nearly Every Day 3 5
Feeling tired: Not at All 52 53
Feeling tired: Several Days 43 40
Feeling tired: More Than Half the Days 12 14
Feeling tired: Nearly Every Day 0 1
Poor appetite/overeating: Not at All 75 71
Poor appetite/overeating: Several Days 24 26
Poor appetite/overeating: More Than Half the Days 5 5
Poor appetite/overeating: Nearly Every Day 3 6
Feeling bad about self: Not at All 92 88
Feeling bad about self: Several Days 12 13
Feeling bad about self: More Than Half the Days 2 3
Feeling bad about self: Nearly Every Day 1 4
Trouble concentrating: Not at All 79 84
Trouble concentrating: Several Days 23 20
Trouble concentrating: More Than Half the Days 2 3
Trouble concentrating: Nearly Every Day 3 1
Move or speak slow/fidgety: Not at All 87 86
Move or speak slow/fidgety: Several Days 18 16
Move or speak slow/fidget: More Than Half the Days 0 3
Move or speak slow/fidgety: Nearly Every Day 2 3
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Pregabalin-Pregabalin Placebo-Pregabalin
Hide Arm/Group Description Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period. Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
All-Cause Mortality
Pregabalin-Pregabalin Placebo-Pregabalin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin-Pregabalin Placebo-Pregabalin
Affected / at Risk (%) Affected / at Risk (%)
Total   4/108 (3.70%)   3/109 (2.75%) 
Blood and lymphatic system disorders     
Idiopathic thrombocytopenic purpura * 1  0/108 (0.00%)  1/109 (0.92%) 
Infections and infestations     
Cellulitis * 1  1/108 (0.93%)  0/109 (0.00%) 
Gastroenteritis * 1  0/108 (0.00%)  1/109 (0.92%) 
HIV infection * 1  1/108 (0.93%)  0/109 (0.00%) 
Injury, poisoning and procedural complications     
Facial bones fracture * 1  0/108 (0.00%)  1/109 (0.92%) 
Muscle strain * 1  1/108 (0.93%)  0/109 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Kaposi’s sarcoma * 1  0/108 (0.00%)  1/109 (0.92%) 
Nervous system disorders     
Transient ischaemic attack * 1  1/108 (0.93%)  0/109 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin-Pregabalin Placebo-Pregabalin
Affected / at Risk (%) Affected / at Risk (%)
Total   35/108 (32.41%)   50/109 (45.87%) 
General disorders     
Oedema peripheral * 1  2/108 (1.85%)  6/109 (5.50%) 
Infections and infestations     
Influenza * 1  5/108 (4.63%)  7/109 (6.42%) 
Pharyngitis * 1  2/108 (1.85%)  6/109 (5.50%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  6/108 (5.56%)  2/109 (1.83%) 
Nervous system disorders     
Dizziness * 1  10/108 (9.26%)  19/109 (17.43%) 
Headache * 1  5/108 (4.63%)  8/109 (7.34%) 
Somnolence * 1  9/108 (8.33%)  14/109 (12.84%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
The parent double blind trial A0081244 (NCT01049217) was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01145417     History of Changes
Other Study ID Numbers: A0081251
First Submitted: June 7, 2010
First Posted: June 16, 2010
Results First Submitted: May 7, 2013
Results First Posted: June 27, 2013
Last Update Posted: June 27, 2013