Rifaximin for Prevention of Travellers' Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742469
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : April 27, 2017
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Diarrhea Drug: Rifaximin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
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
Study Start Date : June 2005
Actual Primary Completion Date : September 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Rifaximin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Drug: Rifaximin
Placebo Comparator: 2
Drug: Placebo

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00742469

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

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
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 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