Trial · NCT01145417
Pregabalin Trial In HIV Neuropathic Pain
NCT01145417, Phase 3, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2013-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pregabalin Trial In HIV Neuropathic Pain. Trials, record NCT01145417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01145417
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregabalin Trial In HIV Neuropathic Pain
- NCT number
- NCT01145417
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 217 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- HIV-1 Infection, Neuropathic Pain
- Interventions
- pregabalin (Lyrica)
- First posted
- 2010-06-16
- Last updated
- 2021-01-28
- Results first posted
- 2013-06-27
- Limitations and caveats
- The parent double blind trial A0081244 (NCT01049217) was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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. | participants | NUMBER |
| SECONDARY | Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, Week 24 | 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. | participants | NUMBER |
| SECONDARY | Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, Week 24 | 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. | hours | MEAN |
| SECONDARY | Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, Week 24 | 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. | Units on a scale | MEAN |
| SECONDARY | 36-Item Short-Form Health Survey (SF-36) | Baseline, Week 24 | 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. | Units on a scale | MEAN |
| SECONDARY | Visual Analogue Scale for Pain (VAS-pain) | Baseline, Week 4, 8, 12, 16, 20, 24 | 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. | millimeter (mm) | MEAN |
| SECONDARY | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Week 24 | 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. | participants | NUMBER |
| 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 | Baseline up to Week 25 | SAF included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment. | participants | NUMBER |
| SECONDARY | Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) | Baseline | 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. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group170
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Pregabalin-Pregabalin | AEs | 67 | participants | |
| Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo-Pregabalin | AEs | 70 | participants | |
| Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Pregabalin-Pregabalin | SAEs | 4 | participants | |
| Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo-Pregabalin | SAEs | 3 | participants | |
| Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Pregabalin-Pregabalin | Baseline, employed (n=52,51) | 12 | participants | |
| Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Placebo-Pregabalin | Baseline, employed (n=52,51) | 11 | participants | |
| Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Pregabalin-Pregabalin | Baseline, unemployed (n=52,51) | 40 | participants | |
| Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Placebo-Pregabalin | Baseline, unemployed (n=52,51) | 40 | participants | |
| Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Pregabalin-Pregabalin | Week 24, employed (n=103,104) | 35 | participants | |
| Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Placebo-Pregabalin | Week 24, employed (n=103,104) | 27 | participants |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin-Pregabalin | 108 | |
| Overall Study | STARTED | Placebo-Pregabalin | 109 | |
| Overall Study | COMPLETED | Pregabalin-Pregabalin | 67 | |
| Overall Study | COMPLETED | Placebo-Pregabalin | 62 | |
| Overall Study | NOT COMPLETED | Pregabalin-Pregabalin | 41 | |
| Overall Study | NOT COMPLETED | Placebo-Pregabalin | 47 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oedema peripheral | General disorders | Pregabalin-Pregabalin | 2 | 108 | |
| other | Oedema peripheral | General disorders | Placebo-Pregabalin | 6 | 109 | |
| other | Influenza | Infections and infestations | Pregabalin-Pregabalin | 5 | 108 | |
| other | Influenza | Infections and infestations | Placebo-Pregabalin | 7 | 109 | |
| other | Pharyngitis | Infections and infestations | Pregabalin-Pregabalin | 2 | 108 | |
| other | Pharyngitis | Infections and infestations | Placebo-Pregabalin | 6 | 109 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Pregabalin-Pregabalin | 6 | 108 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo-Pregabalin | 2 | 109 | |
| other | Dizziness | Nervous system disorders | Pregabalin-Pregabalin | 10 | 108 | |
| other | Dizziness | Nervous system disorders | Placebo-Pregabalin | 19 | 109 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin-Pregabalin | ||
| Total, all-cause mortality | Placebo-Pregabalin | ||
| Total, other adverse events | Pregabalin-Pregabalin | 35 | 108 |
| Total, other adverse events | Placebo-Pregabalin | 50 | 109 |
| Total, serious adverse events | Pregabalin-Pregabalin | 4 | 108 |
| Total, serious adverse events | Placebo-Pregabalin | 3 | 109 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24907403 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pregabalin-Pregabalin vs Placebo-Pregabalin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01145417
GET https://conductscience.org/api/trials/v1/NCT01145417/results?page=2