Travelers' Diarrhea Clinical Trial
Official title:
A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center, Therapeutic Equivalence Study to Compare Rifaximin 200 mg Tablets (Sandoz GmbH) to Xifaxan® 200 mg Tablets (Salix Pharmaceuticals, Inc.) and Placebo in Patients With Travelers' Diarrhea
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.
n/a
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