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NCT00264875 · ClinicalTrials.gov registry record · Phase 3
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy
A Phase 3 study of HIV Infections and Peripheral Neuropathy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT00264875: Completed Phase 3 study of HIV Infections and Peripheral Neuropathy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00264875 is a Phase 3 study of HIV Infections and Peripheral Neuropathy that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 220 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00264875, a Phase 3 study of HIV Infections and Peripheral Neuropathy, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy
Primary Outcome
Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit.
Conditions Studied
Interventions
- DRUG pregabalin
Study Locations (20)
California
- Pfizer Investigational Site - Los Angeles
- Pfizer Investigational Site - Los Angeles
- Pfizer Investigational Site - Sacramento
- Pfizer Investigational Site - San Diego
- Pfizer Investigational Site - San Francisco
- Pfizer Investigational Site - Stanford
- Pfizer Investigational Site - West Hollywood
Florida
- Pfizer Investigational Site - Miami
- Pfizer Investigational Site - Pensacola
- Pfizer Investigational Site - Safety Harbor
- Pfizer Investigational Site - Vero Beach
- Pfizer Investigational Site - West Palm Beach
Illinois
- Pfizer Investigational Site - Chicago
- Pfizer Investigational Site - Chicago
Arizona
- Pfizer Investigational Site - Phoenix
Arkansas
- Pfizer Investigational Site - Little Rock
Colorado
- Pfizer Investigational Site - Denver
Georgia
- Pfizer Investigational Site - Atlanta
Maryland
- Pfizer Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00264875 record still lists
NCT00264875 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (51% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which pregabalin is the first listed.
NCT00264875 names 20 study sites across 9 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00264875 about?
NCT00264875 is a clinical study titled "Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy". To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy
What is the current status of trial NCT00264875?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2006-02. Estimated completion is 2008-02.
What conditions does trial NCT00264875 study?
This clinical trial studies the following conditions: HIV Infections, Peripheral Neuropathy.
What interventions are being tested in trial NCT00264875?
The interventions under investigation include: pregabalin (DRUG).
Who is sponsoring clinical trial NCT00264875?
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.
Where is trial NCT00264875 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00264875's enrollment target sits among peer trials
220 158th of 542 higher than 383 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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