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NCT01049217 · ClinicalTrials.gov registry record · Phase 3
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Terminated
- Registry status
- Phase 3
- Development phase
- 377
- Enrollment target
NCT01049217: Clinical Trial Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01049217 is a Phase 3 study that was terminated before completion, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 377 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01049217, a Phase 3 study, was terminated before completion, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 377 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
Primary Outcome
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward
Interventions
- DRUG placebo
- DRUG pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 377 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
Why NCT01049217 stopped before completion
NCT01049217 is an interventional study that assigns participants to a tested intervention. The registered 377 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01049217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01049217 about?
NCT01049217 is a clinical study titled "Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy". The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
What is the current status of trial NCT01049217?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 377 participants. The study started on 2010-04. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01049217?
The interventions under investigation include: placebo (DRUG), pregabalin (DRUG).
Who is sponsoring clinical trial NCT01049217?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01049217's enrollment target sits among peer trials
377 988th of 2000 higher than 1,013 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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