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NCT00461526 · ClinicalTrials.gov registry record · Phase 2
Diarrhea Predominant Irritable Bowel Syndrome in Females
A Phase 2 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT00461526 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 240 participants.
The verdict
NCT00461526, a Phase 2 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study Summary
Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS) The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome. The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be administered orally twice a day. Subjects will be not able to remain on certain standard IBS medications (anti-diarrheals) while participating in the study. The total duration of the study is 18 weeks. The study requires five study visits that include physical exams, ECG, blood draws, laboratory studies, and a colon procedure (such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years.) Participants will be asked to make entries into a touch-tone telephone diary on a daily basis. Participants must meet all of the following criteria: * Females at least 18 years of age * Diagnosis of diarrhea predominant Irritable Bowel Syndrome * Willingness to make daily calls on a touch-tone telephone * Willingness to have an endoscopic and/or radiologic bowel evaluation, if you have not received one in the past 5 years. * Willingness to take an approved method of birth control (if required) Participants CANNOT meet any of the following criteria: * Serious medical or surgical conditions * Colon Cancer, Crohns Disease or Ulcerative Colitis * Pregnant or breast feeding
Interventions
- DRUG crofelemer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2006-10 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00461526
The ClinicalTrials.gov registry entry for NCT00461526 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which crofelemer is the first listed.
NCT00461526 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00461526 about?
NCT00461526 is a clinical study titled "Diarrhea Predominant Irritable Bowel Syndrome in Females". Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS) The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome. The investigational drug is a natural product ...
What is the current status of trial NCT00461526?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2006-10. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00461526?
The interventions under investigation include: crofelemer (DRUG).
Who is sponsoring clinical trial NCT00461526?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
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