At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 835 enrolled
Drug / intervention
Rifamycin SV-MMX® +1 moredrug
Likely dose
Rifamycin SV-MMX® 200 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 Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy and Safety of Oral Daily Rifamycin SV-MMX® 400 mg b.i.d. vs. Ciprofloxacin 500 mg b.i.d. in the Treatment of Acute Infectious Diarrhoea in Travellers
In Brief
A Phase 3 clinical trial evaluating Rifamycin SV-MMX® and Ciprofloxacin for Traveler's Diarrhea. Completed, enrolled 835 participants across 19 sites in 3 countries.
Detailed Summary
The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraveler's Diarrhea
CountriesEcuador, Guatemala, India
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartNov 2010
Primary CompletionJan 2016
Study CompletionMay 2016
TodayJul 2026
First PostedSep 24, 2010
Enrollment StartNov 1, 2010
Primary CompletionJan 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 15.8 years ago
Interventions
Rifamycin SV-MMX®drug
2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
Ciprofloxacindrug
1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.