NCT02920242

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Travelers' Diarrhea

Interventions

Type	Name	Description
DRUG	Rifaximin (Sandoz GmbH) tablet	200 mg tablet administered orally.
DRUG	Rifaximin (Xifaxan)	200 mg tablet administered orally
DRUG	Placebo	Matching Placebo tablet administered orally

Timeline

• Start date: 2016-12-15
• Primary completion: 2017-05-23
• Completion: 2017-05-23
• First posted: 2016-09-30
• Last updated: 2019-03-25
• Results posted: 2019-03-25

Locations

1 site across 1 country: Mexico