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NCT00269412 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
A Phase 2 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 525
- Enrollment target
NCT00269412 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 525 participants.
The verdict
NCT00269412, a Phase 2 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 525 participants
- Enrollment target
Study Summary
This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550 mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the Post-treatment Phase will be discontinued from the study.
Interventions
- DRUG Rifaximin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 525 participants |
| Start Date | 2005-12 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00269412
The ClinicalTrials.gov registry entry for NCT00269412 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 525 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 Rifaximin is the first listed.
NCT00269412 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00269412 about?
NCT00269412 is a clinical study titled "Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome". This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550 mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional two weeks of placebo f...
What is the current status of trial NCT00269412?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 525 participants. The study started on 2005-12. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00269412?
The interventions under investigation include: Rifaximin (DRUG).
Who is sponsoring clinical trial NCT00269412?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
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