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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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