Trial · NCT00232141
Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
NCT00232141, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy. Trials, record NCT00232141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00232141
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
- NCT number
- NCT00232141
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 302 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- HIV Infections, Peripheral Neuropathy
- Interventions
- pregabalin, Placebo
- First posted
- 2005-10-04
- Last updated
- 2021-02-09
- Results first posted
- 2009-08-11
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Baseline, Week 14 | Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain). |
| Secondary | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Baseline, Week 14 | Change from baseline in MOS-Sleep subscales \& Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 - 100 and higher scores reflect more impairment. Subscales "sleep adequacy", "quantity of sleep" and "optimal sleep" low scores reflect impairment. |
| Secondary | Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales | Baseline, Week 14 | Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21). |
| Secondary | Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores | Baseline, Week 14 | Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from "no pain" (0) to "pain as bad as you can imagine" (10) |
| Secondary | Change From Baseline for NRS-Sleep Interference Scores | Baseline, Week 14 | 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]) |
| Secondary | Categorized Patient Global Impression of Change (PGIC) | Baseline, Week 14 | The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7). |
| Secondary | Patient Global Impression of Change (PGIC) Rating | Baseline, Week 14, Endpoint-LOCF | PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). |
| Secondary | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Baseline, Week 14 | Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores \& a total intensity score calculated from the 5 pain subscores |
| Secondary | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Baseline, Week 14 | Change in a quantitative assessment of the participants' neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable). |
| Secondary | Change in NRS-Sleep Interference Scores | Baseline, Weeks 1-14 | Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Baseline, Week 14 | ITT population (ie, full analysis set)=all randomized participants who took at least 1 dose \& had at least 1 post-randomization efficacy assessment. The endpoint-LOCF mean value was computed from last 7 diary entries (Day 2 up to and including the day after the last dose w/n Dose-Adjustment or Maintenance phase (up to Day 99). | score on scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Baseline, Weeks 1 - 14 and Endpoint-BOCF | ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward) | ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo), BOCF = modified baseline observation carried forward | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Weeks 1-14 endpoint BOCF | ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo); BOCF = modified baseline observation carried forward | participants | NUMBER |
| SECONDARY | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Baseline, Week 14 | ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales | Baseline, Week 14 | ITT population | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores | Baseline, Week 14 | ITT Population; n = number of participants with data for analysis reported (n=pregabalin, placebo). | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for NRS-Sleep Interference Scores | Baseline, Week 14 | ITT Population | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Categorized Patient Global Impression of Change (PGIC) | Baseline, Week 14 | ITT Population | participants | NUMBER |
| SECONDARY | Patient Global Impression of Change (PGIC) Rating | Baseline, Week 14, Endpoint-LOCF | ITT Population | participants | NUMBER |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group586
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Pregabalin | -2.88 | Standard Error 0.21 | score on scale | |
| Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Placebo | -2.63 | Standard Error 0.21 | score on scale | |
| Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Pregabalin | Week 1 (n=136,133) | -1.14 | Standard Error 0.13 | score on scale |
| Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Placebo | Week 1 (n=136,133) | -0.69 | Standard Error 0.13 | score on scale |
| Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Pregabalin | Week 2 (n=126,132) | -1.92 | Standard Error 0.17 | score on scale |
| Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Placebo | Week 2 (n=126,132) | -1.43 | Standard Error 0.17 | score on scale |
| Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Pregabalin | Week 3 (n=118,121) | -2.36 | Standard Error 0.20 | score on scale |
| Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Placebo | Week 3 (n=118,121) | -1.83 | Standard Error 0.20 | score on scale |
| Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Pregabalin | Week 4 (n=118,124) | -2.66 | Standard Error 0.21 | score on scale |
| Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Placebo | Week 4 (n=118,124) | -2.24 | Standard Error 0.20 | score on scale |
1 to 10 of 586Source ClinicalTrials.gov
See all 586 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 | 151 | |
| Overall Study | STARTED | Placebo | 151 | |
| Overall Study | COMPLETED | Pregabalin | 120 | |
| Overall Study | COMPLETED | Placebo | 125 | |
| Overall Study | NOT COMPLETED | Pregabalin | 31 | |
| Overall Study | NOT COMPLETED | Placebo | 26 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00232141
GET https://conductscience.org/api/trials/v1/NCT00232141/registered?page=2