At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 264 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Rifamycin SV MMX 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Rifamycin SV MMX for the Treatment of Traveler's Diarrhea
In Brief
A Phase 3 clinical trial evaluating Placebo and Rifamycin SV MMX for Traveler's Diarrhea. Completed, enrolled 264 participants across 12 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective treatment for Traveler's Diarrhea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraveler's Diarrhea
CountriesGuatemala, Mexico
CollaboratorsBausch Health Americas, Inc.
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedJun 2010
Primary CompletionJun 2012
TodayJul 2026
First PostedJun 11, 2010
Enrollment StartMay 27, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 16.1 years ago
Interventions
Placebodrug
Placebo (two matching tablets) orally twice daily for 3 days (72 hours).
Rifamycin SV MMXdrug
Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).