HIV-1 Infection, Neuropathic Pain
Conditions
Keywords
peripheral neuropathic pain, pregabalin, safety
Brief summary
This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.
Detailed description
The parent double blind study was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated simultaneously on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.
Interventions
150 mg-600 mg/day (twice daily)
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who participated in the preceding A0081244 double-blind trial and completed at least through Visit 9 of that trial. Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on investigator's clinical judgment. Subjects who had acceptable tolerability of study drug in A0081244.
Exclusion criteria
* Clinically significant or unstable conditions that, in the opinion of the investigator, would compromise participation in the study. This includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, psychiatric illness, and untreated endocrine disorders. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. * Active Acquired Immune Deficiency Syndrome (AIDS)- defining Opportunistic Infection (OI) that requires hospitalization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose of study treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, Week 24 | 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. |
| Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, Week 24 | 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). |
| 36-Item Short-Form Health Survey (SF-36) | Baseline, Week 24 | 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). |
| Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, Week 24 | 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. |
| Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Week 24 | 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. |
| Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline up to Week 25 | 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. |
| Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Baseline | 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. |
| Visual Analogue Scale for Pain (VAS-pain) | Baseline, Week 4, 8, 12, 16, 20, 24 | 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. |
Countries
Colombia, India, Peru, Puerto Rico, South Africa, Thailand, United States
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 108 |
| 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. | 109 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Study terminated by sponsor | 35 | 43 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Pregabalin-Pregabalin | Placebo-Pregabalin | Total |
|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 8.8 | 43.5 years STANDARD_DEVIATION 7.9 | 42.9 years STANDARD_DEVIATION 8.4 |
| Sex: Female, Male Female | 71 Participants | 68 Participants | 139 Participants |
| Sex: Female, Male Male | 37 Participants | 41 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 108 | 50 / 109 |
| serious Total, serious adverse events | 4 / 108 | 3 / 109 |
Outcome results
Primary
Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin-Pregabalin | Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 67 participants |
| Pregabalin-Pregabalin | Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 4 participants |
| Placebo-Pregabalin | Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 70 participants |
| Placebo-Pregabalin | Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 participants |
Secondary
36-Item Short-Form Health Survey (SF-36)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: BP (n=51,53) | 68.86 Units on a scale | Standard Deviation 20.43 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: GH (n=51,53) | 72.25 Units on a scale | Standard Deviation 20.369 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: Ph C (n=51,53) | 47.68 Units on a scale | Standard Deviation 7.268 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: BP (n=102,104) | 69.57 Units on a scale | Standard Deviation 22.55 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: GH (n=103,104) | 73.14 Units on a scale | Standard Deviation 19.933 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: Ph C (n=102,104) | 47.28 Units on a scale | Standard Deviation 8.77 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: Vit (n=103,104) | 68.51 Units on a scale | Standard Deviation 18.502 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: MnH (n=103,104) | 76.21 Units on a scale | Standard Deviation 18.196 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: Ph Fn (n=51,53) | 73.14 Units on a scale | Standard Deviation 22.671 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: R-P (n=51,53) | 75.49 Units on a scale | Standard Deviation 22.873 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: R-E (n=51,53) | 81.05 Units on a scale | Standard Deviation 20.075 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: MnH (n=51,53) | 76.27 Units on a scale | Standard Deviation 18.079 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: Mn C (n=51,53) | 51.41 Units on a scale | Standard Deviation 8.915 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: Vit (n=51,53) | 71.57 Units on a scale | Standard Deviation 19.418 |
| Pregabalin-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: So Fn (n=51,53) | 78.92 Units on a scale | Standard Deviation 18.113 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: MnH (n=103,104) | 75.77 Units on a scale | Standard Deviation 18.588 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: BP (n=51,53) | 68.87 Units on a scale | Standard Deviation 26.01 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: Mn C (n=51,53) | 52.71 Units on a scale | Standard Deviation 7.763 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: GH (n=51,53) | 68.79 Units on a scale | Standard Deviation 20.411 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: Ph Fn (n=51,53) | 75.47 Units on a scale | Standard Deviation 22.729 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: Ph C (n=51,53) | 46.85 Units on a scale | Standard Deviation 9.578 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: Vit (n=51,53) | 73.11 Units on a scale | Standard Deviation 17.66 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: R-P (n=103,104) | 72.96 Units on a scale | Standard Deviation 26.68 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: So Fn (n=51,53) | 82.08 Units on a scale | Standard Deviation 18.911 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: BP (n=102,104) | 72.19 Units on a scale | Standard Deviation 23.033 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: R-P (n=51,53) | 71.93 Units on a scale | Standard Deviation 27.616 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: GH (n=103,104) | 71.31 Units on a scale | Standard Deviation 19.879 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: Ph Fn (n=103,104) | 75.24 Units on a scale | Standard Deviation 25.086 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: Ph C (n=102,104) | 48.48 Units on a scale | Standard Deviation 8.634 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: R-E (n=51,53) | 79.87 Units on a scale | Standard Deviation 23.367 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: Vit (n=103,104) | 66.29 Units on a scale | Standard Deviation 20.039 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: Mn C (n=102,104) | 49.72 Units on a scale | Standard Deviation 9.884 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: So Fn (n=103,104) | 81.85 Units on a scale | Standard Deviation 20.304 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Baseline: MnH (n=51,53) | 80.00 Units on a scale | Standard Deviation 15.411 |
| Placebo-Pregabalin | 36-Item Short-Form Health Survey (SF-36) | Week 24: R-E (n=103,104) | 75.80 Units on a scale | Standard Deviation 25.64 |
Secondary
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Placebo-Pregabalin | 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) | 7.71 hours | Standard Deviation 14.976 |
| Placebo-Pregabalin | 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) | 0.82 hours | Standard Deviation 2.401 |
| Placebo-Pregabalin | 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) | 2.32 hours | Standard Deviation 8.533 |
| Placebo-Pregabalin | Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, hours missed,other reason (n=12,11) | 0.91 hours | Standard Deviation 1.7 |
| Placebo-Pregabalin | Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Week 24, hours worked (n=35,28) | 34.86 hours | Standard Deviation 21.329 |
| Placebo-Pregabalin | Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, hours worked (n=12,11) | 30.36 hours | Standard Deviation 18.112 |
Secondary
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Placebo-Pregabalin | 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) | 77 participants |
| Placebo-Pregabalin | 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) | 11 participants |
| Placebo-Pregabalin | 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) | 27 participants |
| Placebo-Pregabalin | 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 |
Secondary
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | No Change | 2 participants |
| Pregabalin-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Improved | 41 participants |
| Pregabalin-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Worse | 1 participants |
| Pregabalin-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Worse | 0 participants |
| Pregabalin-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Improved | 16 participants |
| Pregabalin-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Worse | 0 participants |
| Pregabalin-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Improved | 43 participants |
| Placebo-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Worse | 0 participants |
| Placebo-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Improved | 37 participants |
| Placebo-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Improved | 47 participants |
| Placebo-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Improved | 16 participants |
| Placebo-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | No Change | 3 participants |
| Placebo-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Worse | 1 participants |
| Placebo-Pregabalin | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Worse | 0 participants |
Secondary
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble with sleep: Not at All | 57 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Little interest in things: Several Days | 31 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Little interest in things: More Than Half the Days | 14 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Little interest in things: Nearly Every Day | 3 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling down: Not at All | 84 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling down: Several Days | 18 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling down: More Than Half the Days | 5 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling down: Nearly Every Day | 0 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Little interest in things: Not at All | 59 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble with sleep: Several Days | 33 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble with sleep: More Than Half the Days | 14 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble with sleep: Nearly Every Day | 3 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling tired: Not at All | 52 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling tired: Several Days | 43 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling tired: More Than Half the Days | 12 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling tired: Nearly Every Day | 0 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Poor appetite/overeating: Not at All | 75 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Poor appetite/overeating: Several Days | 24 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Poor appetite/overeating: More Than Half the Days | 5 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Poor appetite/overeating: Nearly Every Day | 3 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling bad about self: Not at All | 92 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling bad about self: Several Days | 12 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling bad about self: More Than Half the Days | 2 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling bad about self: Nearly Every Day | 1 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble concentrating: Not at All | 79 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble concentrating: Several Days | 23 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble concentrating: More Than Half the Days | 2 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble concentrating: Nearly Every Day | 3 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Move or speak slow/fidgety: Not at All | 87 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Move or speak slow/fidgety: Several Days | 18 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Move or speak slow/fidget: More Than Half the Days | 0 participants |
| Pregabalin-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Move or speak slow/fidgety: Nearly Every Day | 2 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Move or speak slow/fidgety: Nearly Every Day | 3 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Little interest in things: Not at All | 67 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Poor appetite/overeating: Not at All | 71 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Little interest in things: Several Days | 25 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble concentrating: Not at All | 84 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Little interest in things: More Than Half the Days | 9 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Poor appetite/overeating: Several Days | 26 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Little interest in things: Nearly Every Day | 7 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Move or speak slow/fidgety: Not at All | 86 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling down: Not at All | 79 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Poor appetite/overeating: More Than Half the Days | 5 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling down: Several Days | 21 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble concentrating: Several Days | 20 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling down: More Than Half the Days | 6 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Poor appetite/overeating: Nearly Every Day | 6 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling down: Nearly Every Day | 2 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Move or speak slow/fidget: More Than Half the Days | 3 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble with sleep: Not at All | 59 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling bad about self: Not at All | 88 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble with sleep: Several Days | 40 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble concentrating: More Than Half the Days | 3 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble with sleep: More Than Half the Days | 4 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling bad about self: Several Days | 13 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble with sleep: Nearly Every Day | 5 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Move or speak slow/fidgety: Several Days | 16 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling tired: Not at All | 53 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling bad about self: More Than Half the Days | 3 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling tired: Several Days | 40 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Trouble concentrating: Nearly Every Day | 1 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling tired: More Than Half the Days | 14 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling bad about self: Nearly Every Day | 4 participants |
| Placebo-Pregabalin | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Feeling tired: Nearly Every Day | 1 participants |
Secondary
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
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
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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Placebo-Pregabalin | 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 | 1 participants |
| Placebo-Pregabalin | 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 | 1 participants |
| Placebo-Pregabalin | 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 | 9 participants |
Secondary
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin-Pregabalin | 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 2.33 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Pregabalin-Pregabalin | 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 |
| Placebo-Pregabalin | 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) | 2.72 Units on a scale | Standard Deviation 2.653 |
| Placebo-Pregabalin | Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, productivity affected (n=12,10) | 2.40 Units on a scale | Standard Deviation 2.716 |
| Placebo-Pregabalin | Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Week 24, productivity affected (n=35,29) | 2.24 Units on a scale | Standard Deviation 2.415 |
| Placebo-Pregabalin | Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, daily activity affected (n=52,51) | 3.47 Units on a scale | Standard Deviation 2.935 |
Secondary
Visual Analogue Scale for Pain (VAS-pain)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 8 (n=100,101) | 27.4 millimeter (mm) | Standard Deviation 21.01 |
| Pregabalin-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 16 (n=85,81) | 22.6 millimeter (mm) | Standard Deviation 20.82 |
| Pregabalin-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Baseline (n=107,108) | 40.6 millimeter (mm) | Standard Deviation 26.55 |
| Pregabalin-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 20 (n=72,67) | 17.2 millimeter (mm) | Standard Deviation 19.18 |
| Pregabalin-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 12 (n=89,88) | 24.1 millimeter (mm) | Standard Deviation 22.41 |
| Pregabalin-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 24 (n=103,104) | 22.2 millimeter (mm) | Standard Deviation 22.54 |
| Pregabalin-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 4 (n=106,106) | 33.1 millimeter (mm) | Standard Deviation 25.14 |
| Placebo-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 24 (n=103,104) | 23.7 millimeter (mm) | Standard Deviation 23.94 |
| Placebo-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 4 (n=106,106) | 33.1 millimeter (mm) | Standard Deviation 27.11 |
| Placebo-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Baseline (n=107,108) | 40.7 millimeter (mm) | Standard Deviation 26.57 |
| Placebo-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 8 (n=100,101) | 27.8 millimeter (mm) | Standard Deviation 24.25 |
| Placebo-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 12 (n=89,88) | 23.8 millimeter (mm) | Standard Deviation 23.45 |
| Placebo-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 16 (n=85,81) | 22.6 millimeter (mm) | Standard Deviation 25.32 |
| Placebo-Pregabalin | Visual Analogue Scale for Pain (VAS-pain) | Week 20 (n=72,67) | 17.7 millimeter (mm) | Standard Deviation 22.78 |