Phase 3
N=210
Rifaximin for Prevention of Travellers' Diarrhea
Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT00742469 ↗Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment — 15; 48 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rifaximin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Sep 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment |
15; 48 | — |
Summary
The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.
Eligibility Criteria
Inclusion Criteria
- travelling to Mexico within 72 hours of enrollment
- read and understand English
- in good health
Exclusion Criteria
- acute diarrhea within previous 7 days
- taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.
- taken antidiarrheal medication within 24 hours of enrollment or anytime during study.
Data sourced from ClinicalTrials.gov (NCT00742469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.