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A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
NCT00101725 · View on ClinicalTrials.gov ↗
Study Summary
This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).
Conditions Studied
Interventions
- DRUG crofelemer
Study Locations (20)
California
- AGMG Clinical Research Institute — Anaheim
- Community Clinical Trials — Orange
- AGMG Clinical Research — Orange
- Institute of Healthcare Assessment, Inc. — San Diego
North Carolina
- LeBauer Research Associates, PA — Greensboro
- Medoff Medical / Vital Research — Greensboro
- Hanover Medical Specialists, PA — Wilmington
- Piedmont Medical Research Assoc., Inc. — Winston-Salem
Florida
- Consultants for Clinical Research of South Florida — Boynton Beach
- University Clinical Research DeLand — DeLand
Alabama
- Clinical Research Associates — Huntsville
Arizona
- Radiant Research Phoenix Southeast — Chandler
Arkansas
- Arkansas Gastroenterology — North Little Rock
District of Columbia
- Washington Gastroenterology — Washington D.C.
Illinois
- nTouch Research — Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2004-12 |
| Est. Completion | 2005-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00101725
The ClinicalTrials.gov registry entry for NCT00101725 describes a study currently listed as completed. It is categorized as Phase 2, 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 245 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 4 conditions, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention — of which crofelemer 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: NCT00101725 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, North Carolina, Florida. 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 NCT00101725 about?
NCT00101725 is a clinical study titled "A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome". This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).
What is the current status of trial NCT00101725?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 245 participants. The study started on 2004-12. Estimated completion is 2005-11.
What conditions does trial NCT00101725 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome, Diarrhea, Gastrointestinal Disease, Colonic Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00101725?
The interventions under investigation include: crofelemer (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00101725?
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 NCT00101725 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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