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Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
NCT00547898 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00547898
The ClinicalTrials.gov registry entry for NCT00547898 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 374 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00547898 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00547898?
This trial is sponsored by Bausch Health Americas, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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