CompletedPhase 3

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

United States660 participantsStarted 2005-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

The primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo.

Trial details

NCT IDNCT00328380

SponsorBausch Health Americas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-12

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