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Clinical Trial Summary

This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet.

It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The remaining 27 patients received study drug and 25 patients completed the study.

The study was terminated due to slow enrolment. The final analysis included only safety analysis in the Safety population, due to the low number of randomized patients. No efficacy analysis was performed.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02920242
Study type Interventional
Source Sandoz
Contact
Status Terminated
Phase Phase 3
Start date December 15, 2016
Completion date May 23, 2017

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