Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
Completed · Phase 3
Conditions studied: Diarrhea
In brief
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.
Key facts
- Study ID
- NCT00328380
- Run by
- Bausch Health Americas, Inc.
- People needed
- 660
- Starts
- 2005-12-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2019-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subject is in good health (as determined by medical history)
- Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days
- 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)
You may not qualify if…
- Subject has hypersensitivity or allergy to rifaximin or rifampin
- Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment
- Subject participated in an investigational drug or device study within the 30 days prior to enrollment
- Subject received rifaximin in a previous clinical study
- Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug
- Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug
Where it is running
- Sunshine Medical Center — South Miami, Florida, United States
- Southwest Doctors, PA — Houston, Texas, United States
- La Porte Family Clinic — La Porte, Texas, United States
Full record on ClinicalTrials.gov
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