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NCT01543178 · ClinicalTrials.gov registry record · Phase 3
Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study
A Phase 3 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,583
- Enrollment target
NCT01543178: Completed Phase 3 study, sponsored by Bausch Health Americas.
NCT01543178 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 2,583 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (235% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01543178, a Phase 3 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,583 participants
- Enrollment target
Study Summary
This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.
Primary Outcome
Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea.
Interventions
- DRUG open-label rifaximin
- DRUG double-blind placebo
- DRUG double-blind rifaximin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,583 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01543178 record still lists
NCT01543178 is an interventional study that assigns participants to a tested intervention. Its 2,583 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (235% higher).
The record links to 0 conditions, and to 3 interventions - of which open-label rifaximin is the first listed.
NCT01543178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01543178 about?
NCT01543178 is a clinical study titled "Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study". This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.
What is the current status of trial NCT01543178?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,583 participants. The study started on 2012-02. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01543178?
The interventions under investigation include: open-label rifaximin (DRUG), double-blind placebo (DRUG), double-blind rifaximin (DRUG).
Who is sponsoring clinical trial NCT01543178?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01543178's enrollment target sits among peer trials
2,583 85th of 2000 higher than 1,916 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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