At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 739 enrolled
Drug / intervention
Rifaximin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Rifaximin 200-mg Tablets With Xifaxan® 200-mg Tablets in the Treatment of Travelers' Diarrhea
In Brief
A Phase 3 clinical trial evaluating Rifaximin, Xifaxan®, and 1 other intervention for Diarrhea. Completed, enrolled 739 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartJan 2016
Primary CompletionFeb 2017
TodayJul 2026
First PostedJul 15, 2015
Enrollment StartJan 6, 2016
Primary CompletionFeb 28, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.0 years ago
Interventions
Rifaximindrug
Tablets, generic formulation of the brand product.
Xifaxan®drug
Tablets, brand product.
Placebo Tabletdrug
Placebo tablets in the same image of the generic rifaximin. Has no active ingredient.