Status:
COMPLETED
Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 pre...
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 u...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00328380
Start Date
December 1 2005
End Date
September 1 2008
Last Update
November 25 2019
Active Locations (3)
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1
Sunshine Medical Center
South Miami, Florida, United States, 33143
2
Southwest Doctors, PA
Houston, Texas, United States, 77004
3
La Porte Family Clinic
La Porte, Texas, United States, 77571