A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Rifamycin SV MMX for the Treatment of Traveler's Diarrhea

NCT01142089 Phase 3 COMPLETED Results posted

The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective treatment for Traveler's Diarrhea.

Details

Lead sponsor	Cosmo Technologies Ltd
Phase	Phase 3
Status	COMPLETED
Enrolment	264
Start date	2010-05-27
Completion	2012-06

Conditions

• Traveler's Diarrhea

Interventions

• Placebo
• Rifamycin SV MMX

Primary outcomes

• Time to Last Unformed Stool (TLUS) — 24 hours
  The primary endpoint is TLUS defined as the interval in hours between the first dose of study drug and the last unformed stool passed just before the start of Clinical Cure. An unformed stool is defined as either a soft or watery stool. TLUS will be calculated for each patient in the following manner: Step 1: Identify when the patient achieves Clinical Cure. Step 2: Moving backwards from this time, identify the time of the last unformed stool. Step 3: The TLUS equals the time from the first dose of study drug to the time of the last unformed stool identified in Step 2.

Countries

Guatemala, Mexico