Trials / Terminated
TerminatedNCT01049217
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial Of Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081244)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 377 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
Detailed description
Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pregabalin | Pregabalin 75 mg-300mg twice daily during the course of the study. |
| DRUG | placebo | Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks. |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2012-05-01
- Completion
- 2012-05-01
- First posted
- 2010-01-14
- Last updated
- 2021-01-28
- Results posted
- 2013-07-17
Locations
63 sites across 9 countries: United States, Colombia, Dominican Republic, India, Peru, Poland, Puerto Rico, South Africa, Thailand
Source: ClinicalTrials.gov record NCT01049217. Inclusion in this directory is not an endorsement.