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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

1. Subject is in good health (as determined by medical history)

2. Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days

3. Subject is scheduled to depart on their planned trip no later than 14 days and no earlier than 4 days after having blood drawn for clinical laboratory assessments and urine collected for a pregnancy test (females of childbearing potential only)

Exclusion Criteria:

1. Subject has hypersensitivity or allergy to rifaximin or rifampin

2. Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment

3. Subject participated in an investigational drug or device study within the 30 days prior to enrollment

4. Subject received rifaximin in a previous clinical study

5. Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug

6. Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug