Trial Outcomes & Findings for Pregabalin Trial In HIV Neuropathic Pain (NCT NCT01145417)
NCT ID: NCT01145417
Last Updated: 2021-01-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
217 participants
Primary outcome timeframe
Baseline up to 30 days after last dose of study treatment
Results posted on
2021-01-28
Participant Flow
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).
Participant milestones
| Measure |
Pregabalin-Pregabalin
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.
|
Placebo-Pregabalin
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 Study
STARTED
|
108
|
109
|
|
Overall Study
COMPLETED
|
67
|
62
|
|
Overall Study
NOT COMPLETED
|
41
|
47
|
Reasons for withdrawal
| Measure |
Pregabalin-Pregabalin
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.
|
Placebo-Pregabalin
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 Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Study terminated by sponsor
|
35
|
43
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Pregabalin Trial In HIV Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Pregabalin-Pregabalin
n=108 Participants
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.
|
Placebo-Pregabalin
n=109 Participants
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
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose of study treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Pregabalin-Pregabalin
n=108 Participants
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.
|
Placebo-Pregabalin
n=109 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
67 participants
|
70 participants
|
|
Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
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.
Outcome measures
| Measure |
Pregabalin-Pregabalin
n=103 Participants
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.
|
Placebo-Pregabalin
n=104 Participants
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.
|
|---|---|---|
|
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Baseline, employed (n=52,51)
|
12 participants
|
11 participants
|
|
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Baseline, unemployed (n=52,51)
|
40 participants
|
40 participants
|
|
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Week 24, employed (n=103,104)
|
35 participants
|
27 participants
|
|
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Week 24, unemployed (n=103,104)
|
68 participants
|
77 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
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.
Outcome measures
| Measure |
Pregabalin-Pregabalin
n=35 Participants
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.
|
Placebo-Pregabalin
n=28 Participants
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.
|
|---|---|---|
|
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Baseline, hours worked (n=12,11)
|
35.58 hours
Standard Deviation 15.163
|
30.36 hours
Standard Deviation 18.112
|
|
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Week 24, hours missed,leg/foot pain (n=35,28)
|
2.17 hours
Standard Deviation 4.956
|
2.32 hours
Standard Deviation 8.533
|
|
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Week 24, hours missed,other reason (n=35,28)
|
9.20 hours
Standard Deviation 21.604
|
7.71 hours
Standard Deviation 14.976
|
|
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Week 24, hours worked (n=35,28)
|
41.51 hours
Standard Deviation 20.034
|
34.86 hours
Standard Deviation 21.329
|
|
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Baseline, hours missed,leg/foot pain (n=12,11)
|
2.25 hours
Standard Deviation 6.877
|
0.82 hours
Standard Deviation 2.401
|
|
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Baseline, hours missed,other reason (n=12,11)
|
3.42 hours
Standard Deviation 6.501
|
0.91 hours
Standard Deviation 1.700
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
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).
Outcome measures
| Measure |
Pregabalin-Pregabalin
n=103 Participants
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.
|
Placebo-Pregabalin
n=104 Participants
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.
|
|---|---|---|
|
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Baseline, productivity affected (n=12,10)
|
4.42 Units on a scale
Standard Deviation 2.843
|
2.40 Units on a scale
Standard Deviation 2.716
|
|
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Baseline, daily activity affected (n=52,51)
|
3.48 Units on a scale
Standard Deviation 2.846
|
3.47 Units on a scale
Standard Deviation 2.935
|
|
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Week 24, productivity affected (n=35,29)
|
2.17 Units on a scale
Standard Deviation 1.917
|
2.24 Units on a scale
Standard Deviation 2.415
|
|
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Week 24, daily activity affected (n=103,104)
|
2.51 Units on a scale
Standard Deviation 2.330
|
2.72 Units on a scale
Standard Deviation 2.653
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
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).
Outcome measures
| Measure |
Pregabalin-Pregabalin
n=103 Participants
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.
|
Placebo-Pregabalin
n=104 Participants
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.
|
|---|---|---|
|
36-Item Short-Form Health Survey (SF-36)
Baseline: Ph Fn (n=51,53)
|
73.14 Units on a scale
Standard Deviation 22.671
|
75.47 Units on a scale
Standard Deviation 22.729
|
|
36-Item Short-Form Health Survey (SF-36)
Baseline: R-P (n=51,53)
|
75.49 Units on a scale
Standard Deviation 22.873
|
71.93 Units on a scale
Standard Deviation 27.616
|
|
36-Item Short-Form Health Survey (SF-36)
Baseline: BP (n=51,53)
|
68.86 Units on a scale
Standard Deviation 20.430
|
68.87 Units on a scale
Standard Deviation 26.010
|
|
36-Item Short-Form Health Survey (SF-36)
Week 24: Ph Fn (n=103,104)
|
70.34 Units on a scale
Standard Deviation 27.594
|
75.24 Units on a scale
Standard Deviation 25.086
|
|
36-Item Short-Form Health Survey (SF-36)
Baseline: Mn C (n=51,53)
|
51.41 Units on a scale
Standard Deviation 8.915
|
52.71 Units on a scale
Standard Deviation 7.763
|
|
36-Item Short-Form Health Survey (SF-36)
Week 24: R-P (n=103,104)
|
71.18 Units on a scale
Standard Deviation 24.927
|
72.96 Units on a scale
Standard Deviation 26.680
|
|
36-Item Short-Form Health Survey (SF-36)
Baseline: GH (n=51,53)
|
72.25 Units on a scale
Standard Deviation 20.369
|
68.79 Units on a scale
Standard Deviation 20.411
|
|
36-Item Short-Form Health Survey (SF-36)
Baseline: Ph C (n=51,53)
|
47.68 Units on a scale
Standard Deviation 7.268
|
46.85 Units on a scale
Standard Deviation 9.578
|
|
36-Item Short-Form Health Survey (SF-36)
Baseline: Vit (n=51,53)
|
71.57 Units on a scale
Standard Deviation 19.418
|
73.11 Units on a scale
Standard Deviation 17.660
|
|
36-Item Short-Form Health Survey (SF-36)
Baseline: So Fn (n=51,53)
|
78.92 Units on a scale
Standard Deviation 18.113
|
82.08 Units on a scale
Standard Deviation 18.911
|
|
36-Item Short-Form Health Survey (SF-36)
Baseline: R-E (n=51,53)
|
81.05 Units on a scale
Standard Deviation 20.075
|
79.87 Units on a scale
Standard Deviation 23.367
|
|
36-Item Short-Form Health Survey (SF-36)
Baseline: MnH (n=51,53)
|
76.27 Units on a scale
Standard Deviation 18.079
|
80.00 Units on a scale
Standard Deviation 15.411
|
|
36-Item Short-Form Health Survey (SF-36)
Week 24: BP (n=102,104)
|
69.57 Units on a scale
Standard Deviation 22.550
|
72.19 Units on a scale
Standard Deviation 23.033
|
|
36-Item Short-Form Health Survey (SF-36)
Week 24: GH (n=103,104)
|
73.14 Units on a scale
Standard Deviation 19.933
|
71.31 Units on a scale
Standard Deviation 19.879
|
|
36-Item Short-Form Health Survey (SF-36)
Week 24: Ph C (n=102,104)
|
47.28 Units on a scale
Standard Deviation 8.770
|
48.48 Units on a scale
Standard Deviation 8.634
|
|
36-Item Short-Form Health Survey (SF-36)
Week 24: Vit (n=103,104)
|
68.51 Units on a scale
Standard Deviation 18.502
|
66.29 Units on a scale
Standard Deviation 20.039
|
|
36-Item Short-Form Health Survey (SF-36)
Week 24: So Fn (n=103,104)
|
79.98 Units on a scale
Standard Deviation 20.883
|
81.85 Units on a scale
Standard Deviation 20.304
|
|
36-Item Short-Form Health Survey (SF-36)
Week 24: R-E (n=103,104)
|
74.19 Units on a scale
Standard Deviation 27.029
|
75.80 Units on a scale
Standard Deviation 25.640
|
|
36-Item Short-Form Health Survey (SF-36)
Week 24: MnH (n=103,104)
|
76.21 Units on a scale
Standard Deviation 18.196
|
75.77 Units on a scale
Standard Deviation 18.588
|
|
36-Item Short-Form Health Survey (SF-36)
Week 24: Mn C (n=102,104)
|
50.15 Units on a scale
Standard Deviation 10.394
|
49.72 Units on a scale
Standard Deviation 9.884
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24Population: 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.
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.
Outcome measures
| Measure |
Pregabalin-Pregabalin
n=107 Participants
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.
|
Placebo-Pregabalin
n=108 Participants
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.
|
|---|---|---|
|
Visual Analogue Scale for Pain (VAS-pain)
Baseline (n=107,108)
|
40.6 millimeter (mm)
Standard Deviation 26.55
|
40.7 millimeter (mm)
Standard Deviation 26.57
|
|
Visual Analogue Scale for Pain (VAS-pain)
Week 4 (n=106,106)
|
33.1 millimeter (mm)
Standard Deviation 25.14
|
33.1 millimeter (mm)
Standard Deviation 27.11
|
|
Visual Analogue Scale for Pain (VAS-pain)
Week 8 (n=100,101)
|
27.4 millimeter (mm)
Standard Deviation 21.01
|
27.8 millimeter (mm)
Standard Deviation 24.25
|
|
Visual Analogue Scale for Pain (VAS-pain)
Week 12 (n=89,88)
|
24.1 millimeter (mm)
Standard Deviation 22.41
|
23.8 millimeter (mm)
Standard Deviation 23.45
|
|
Visual Analogue Scale for Pain (VAS-pain)
Week 16 (n=85,81)
|
22.6 millimeter (mm)
Standard Deviation 20.82
|
22.6 millimeter (mm)
Standard Deviation 25.32
|
|
Visual Analogue Scale for Pain (VAS-pain)
Week 20 (n=72,67)
|
17.2 millimeter (mm)
Standard Deviation 19.18
|
17.7 millimeter (mm)
Standard Deviation 22.78
|
|
Visual Analogue Scale for Pain (VAS-pain)
Week 24 (n=103,104)
|
22.2 millimeter (mm)
Standard Deviation 22.54
|
23.7 millimeter (mm)
Standard Deviation 23.94
|
SECONDARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Pregabalin-Pregabalin
n=103 Participants
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.
|
Placebo-Pregabalin
n=104 Participants
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.
|
|---|---|---|
|
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Very Much Improved
|
41 participants
|
37 participants
|
|
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Much Improved
|
43 participants
|
47 participants
|
|
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Minimally Improved
|
16 participants
|
16 participants
|
|
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
No Change
|
2 participants
|
3 participants
|
|
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Minimally Worse
|
1 participants
|
0 participants
|
|
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Much Worse
|
0 participants
|
1 participants
|
|
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Very Much Worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 25Population: SAF included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.
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.
Outcome measures
| Measure |
Pregabalin-Pregabalin
n=108 Participants
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.
|
Placebo-Pregabalin
n=109 Participants
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.
|
|---|---|---|
|
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Suicide attempt: 2
|
0 participants
|
1 participants
|
|
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Preparatory acts toward suicidal behavior: 3
|
0 participants
|
1 participants
|
|
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Suicidal ideation: 4
|
4 participants
|
9 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Pregabalin-Pregabalin
n=107 Participants
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.
|
Placebo-Pregabalin
n=108 Participants
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.
|
|---|---|---|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Little interest in things: Not at All
|
59 participants
|
67 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Little interest in things: Several Days
|
31 participants
|
25 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Little interest in things: More Than Half the Days
|
14 participants
|
9 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Little interest in things: Nearly Every Day
|
3 participants
|
7 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling down: Not at All
|
84 participants
|
79 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling down: Several Days
|
18 participants
|
21 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling down: More Than Half the Days
|
5 participants
|
6 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling down: Nearly Every Day
|
0 participants
|
2 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Trouble with sleep: Not at All
|
57 participants
|
59 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Trouble with sleep: Several Days
|
33 participants
|
40 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Trouble with sleep: More Than Half the Days
|
14 participants
|
4 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Trouble with sleep: Nearly Every Day
|
3 participants
|
5 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling tired: Not at All
|
52 participants
|
53 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling tired: Several Days
|
43 participants
|
40 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling tired: More Than Half the Days
|
12 participants
|
14 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling tired: Nearly Every Day
|
0 participants
|
1 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Poor appetite/overeating: Not at All
|
75 participants
|
71 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Poor appetite/overeating: Several Days
|
24 participants
|
26 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Poor appetite/overeating: More Than Half the Days
|
5 participants
|
5 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Poor appetite/overeating: Nearly Every Day
|
3 participants
|
6 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling bad about self: Not at All
|
92 participants
|
88 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling bad about self: Several Days
|
12 participants
|
13 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling bad about self: More Than Half the Days
|
2 participants
|
3 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Feeling bad about self: Nearly Every Day
|
1 participants
|
4 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Trouble concentrating: Nearly Every Day
|
3 participants
|
1 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Trouble concentrating: Not at All
|
79 participants
|
84 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Trouble concentrating: Several Days
|
23 participants
|
20 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Trouble concentrating: More Than Half the Days
|
2 participants
|
3 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Move or speak slow/fidgety: Not at All
|
87 participants
|
86 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Move or speak slow/fidgety: Several Days
|
18 participants
|
16 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Move or speak slow/fidget: More Than Half the Days
|
0 participants
|
3 participants
|
|
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Move or speak slow/fidgety: Nearly Every Day
|
2 participants
|
3 participants
|
Adverse Events
Pregabalin-Pregabalin
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo-Pregabalin
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin-Pregabalin
n=108 participants at risk
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.
|
Placebo-Pregabalin
n=109 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/108
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.
|
0.92%
1/109
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.
|
|
Infections and infestations
Cellulitis
|
0.93%
1/108
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.
|
0.00%
0/109
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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/108
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.
|
0.92%
1/109
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.
|
|
Infections and infestations
HIV infection
|
0.93%
1/108
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.
|
0.00%
0/109
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.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/108
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.
|
0.92%
1/109
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.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.93%
1/108
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.
|
0.00%
0/109
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/108
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.
|
0.92%
1/109
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.93%
1/108
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.
|
0.00%
0/109
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.
|
Other adverse events
| Measure |
Pregabalin-Pregabalin
n=108 participants at risk
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.
|
Placebo-Pregabalin
n=109 participants at risk
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.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
1.9%
2/108
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.
|
5.5%
6/109
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.
|
|
Infections and infestations
Influenza
|
4.6%
5/108
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.
|
6.4%
7/109
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.
|
|
Infections and infestations
Pharyngitis
|
1.9%
2/108
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.
|
5.5%
6/109
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
6/108
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.
|
1.8%
2/109
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.
|
|
Nervous system disorders
Dizziness
|
9.3%
10/108
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.
|
17.4%
19/109
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.
|
|
Nervous system disorders
Headache
|
4.6%
5/108
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.
|
7.3%
8/109
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.
|
|
Nervous system disorders
Somnolence
|
8.3%
9/108
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.
|
12.8%
14/109
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER