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NCT02498418 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 739
- Enrollment target
NCT02498418: Completed Phase 3 study, sponsored by Actavis.
NCT02498418 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 739 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02498418, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 739 participants
- Enrollment target
Study Summary
The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day (TID) for 3 days in participants with travelers' diarrhea.
Primary Outcome
Clinical cure was defined as either of the following: No stools or only formed stools within a 48-hour period and no fever, with or without other enteric symptoms or; No watery stools or no more than 2 soft stools passed within a 24-hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence. Bioequivalence evaluation between test (generic rifaximin 200 mg tablets) and reference groups (xifaxan 200 mg tablets) was conducted in this endpoint, hence placebo group
Interventions
- DRUG Rifaximin
- DRUG Placebo Tablet
- DRUG Xifaxan®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 739 participants |
| Start Date | 2016-01-06 |
| Est. Completion | 2017-02-28 |
| Phase | Phase 3 |
What the finished NCT02498418 record still lists
NCT02498418 is an interventional study that assigns participants to a tested intervention. The registered 739 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Rifaximin is the first listed.
NCT02498418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02498418 about?
NCT02498418 is a clinical study titled "Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea". The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day (TID) for 3 days in participants with travelers' diarrhea.
What is the current status of trial NCT02498418?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 739 participants. The study started on 2016-01-06. Estimated completion is 2017-02-28.
What interventions are being tested in trial NCT02498418?
The interventions under investigation include: Rifaximin (DRUG), Placebo Tablet (DRUG), Xifaxan® (DRUG).
Who is sponsoring clinical trial NCT02498418?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02498418's enrollment target sits among peer trials
739 478th of 2000 higher than 1,522 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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