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NCT00547898 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
A Phase 3 study of HIV Associated Diarrhea, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 374
- Enrollment target
- 20
- Study locations
NCT00547898: Completed Phase 3 study of HIV Associated Diarrhea, sponsored by Bausch Health Americas.
NCT00547898 is a Phase 3 study of HIV Associated Diarrhea that has completed, run by Bausch Health Americas. The registered enrollment target is 374 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00547898, a Phase 3 study of HIV Associated Diarrhea, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 374 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Crofelemer 125 mg
- DRUG Crofelemer 250 mg
- DRUG Crofelemer 500 mg
Study Locations (20)
California
- - Bakersfield
- - Beverly Hills
- - Beverly Hills
- - Fountain Valley
- - Long Beach
- - Los Angeles
- - Los Angeles
- - Los Angeles
- - Oakland
- - Palm Springs
- - San Diego
- - San Francisco
- - San Mateo
Florida
- - Daytona Beach
- - Fort Lauderdale
- - Fort Lauderdale
Alabama
- - Huntsville
Arizona
- - Phoenix
Arkansas
- - Little Rock
Colorado
- - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-07-11 |
| Phase | Phase 3 |
What the finished NCT00547898 record still lists
NCT00547898 is an interventional study that assigns participants to a tested intervention. The registered 374 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 (52% lower).
The record links to 1 condition, with HIV Associated Diarrhea appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00547898 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00547898 about?
NCT00547898 is a clinical study titled "Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea". This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safe...
What is the current status of trial NCT00547898?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 374 participants. The study started on 2007-10. Estimated completion is 2011-07-11.
What conditions does trial NCT00547898 study?
This clinical trial studies the following conditions: HIV Associated Diarrhea.
What interventions are being tested in trial NCT00547898?
The interventions under investigation include: Placebo (DRUG), Crofelemer 125 mg (DRUG), Crofelemer 250 mg (DRUG), Crofelemer 500 mg (DRUG).
Who is sponsoring clinical trial NCT00547898?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00547898 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00547898's enrollment target sits among peer trials
374 991st of 2000 higher than 1,010 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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