A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.

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.

Inclusion Criteria:

• Patient is able to read and understood the language of the Informed Consent Form and Patient Information.
• International travelers with a duration of stay in host country long enough to attend schedules visits.
• Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization

Exclusion Criteria:

• Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug.
• Pregnant, breast feeding or planning pregnancy
• Acute diarrhea for > 72 hours immediately prior to randomization.
• Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.