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Rifaximin for Prevention of Travellers' Diarrhea

This study has been completed.
Information provided by:
Valeant Pharmaceuticals International, Inc. Identifier:
First received: August 24, 2008
Last updated: April 26, 2017
Last verified: April 2017
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.

Condition Intervention Phase
Diarrhea Drug: Rifaximin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized,Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Rifaximin for the Prevention of Travellers' Diarrhea

Resource links provided by NLM:

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Relative risk of travellers' diarrhea for rifaximin 600 mg QD compared to placebo over 14 days of treatment [ Time Frame: 14 days ]

Enrollment: 210
Study Start Date: June 2005
Study Completion Date: April 2007
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: Rifaximin
Placebo Comparator: 2
Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. travelling to Mexico within 72 hours of enrollment
  2. read and understand English
  3. in good health

Exclusion Criteria:

  1. acute diarrhea within previous 7 days
  2. taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.
  3. taken antidiarrheal medication within 24 hours of enrollment or anytime during study.
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Please refer to this study by its identifier: NCT00742469

University of San Diego
Guadalajara, Jalisco, Mexico, 45090
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: William Forbes, Pharm.D., Salix Pharmaceuticals, Inc. Identifier: NCT00742469     History of Changes
Other Study ID Numbers: RFID3003
Study First Received: August 24, 2008
Last Updated: April 26, 2017

Keywords provided by Valeant Pharmaceuticals International, Inc.:
traveller's diarrhea
E. coli

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents processed this record on August 17, 2017