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OpenTrials
Completed

NCT Number: NCT00742469

Rifaximin for Prevention of Travellers' Diarrhea

The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

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Key information

Conditions

Diarrhea Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Dysentery Dysentery, Bacillary Enterobacteriaceae Infections Escherichia coli Infections Gastroenteritis Gastrointestinal Diseases Gram-Negative Bacterial Infections Infections Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of San Diego

Guadalajara, Jalisco, 45090, Mexico

About this study

To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • travelling to Mexico within 72 hours of enrollment
  • read and understand English
  • in good health

Exclusion criteria

  • acute diarrhea within previous 7 days
  • taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.
  • taken antidiarrheal medication within 24 hours of enrollment or anytime during study.

Treatment and study plan

Rifaximin

Drug

Placebo

Drug

Primary outcomes

  1. Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment

    Time frame: 14 days

    The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

A Randomized,Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Rifaximin for the Prevention of Travellers' Diarrhea

Important dates

Study start
2005
Primary completion
2005
Study completion
2007
First posted
Aug 27, 2008
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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