NCT00328380

Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety of Rifaximin for the Prevention of Travelers' Diarrhea in Subjects Traveling Outside the United States

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD) from all causes.

Detailed description

Travelers' diarrhea (TD) is the most common illness in travelers to the developing world, occurring in 60% or more of international travelers to high-risk areas. It can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans. Findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness. Specifically, persistent diarrhea has been reported in 2% to 10% of travelers developing diarrhea. Moreover, bacterial enterocolitis, including that associated with TD, leads to post-infectious irritable bowel syndrome in 4% to 31% of patients.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	Rifaximin

Timeline

• Start date: 2005-12-01
• Primary completion: 2006-12-01
• Completion: 2008-09-01
• First posted: 2006-05-19
• Last updated: 2019-11-25

Locations

3 sites across 1 country: United States