NCT02498418

Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 739 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, placebo-controlled bioequivalent study with a clinical endpoint in the treatment of travelers' diarrhea. After 3 unformed stools are recorded within the 24 hours immediately preceding randomization, participants are to be randomized to receive the generic rifaximin 200 mg oral tablet, Xifaxan (the reference listed drug)200 mg oral tablet, or placebo 3 times daily for 3 days (that is; on Days 1, 2, and 3).

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	Rifaximin	Tablets, generic formulation of the brand product.
DRUG	Xifaxan®	Tablets, brand product.
DRUG	Placebo Tablet	Placebo tablets in the same image of the generic rifaximin. Has no active ingredient.

Timeline

• Start date: 2016-01-06
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2015-07-15
• Last updated: 2019-12-05
• Results posted: 2019-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study