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Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.

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.
ClinicalTrials.gov Identifier: NCT00328380
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : December 23, 2009
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD) from all causes.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: Rifaximin Phase 3

Detailed Description:
Travelers' diarrhea (TD) is the most common illness in travelers to the developing world, occurring in 60% or more of international travelers to high-risk areas. It can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans. Findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness. Specifically, persistent diarrhea has been reported in 2% to 10% of travelers developing diarrhea. Moreover, bacterial enterocolitis, including that associated with TD, leads to post-infectious irritable bowel syndrome in 4% to 31% of patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety of Rifaximin for the Prevention of Travelers' Diarrhea in Subjects Traveling Outside the United States
Study Start Date : December 2005
Primary Completion Date : December 2006
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. The primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo.

Secondary Outcome Measures :
  1. A secondary endpoints of this study include assessment of the differences between the 2 treatment groups based upon the proportion of subjects with TD during the 14-day Treatment Period.

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Subject is in good health (as determined by medical history)
  2. Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days
  3. Subject is scheduled to depart on their planned trip no later than 14 days and no earlier than 4 days after having blood drawn for clinical laboratory assessments and urine collected for a pregnancy test (females of childbearing potential only)

Exclusion Criteria:

  1. Subject has hypersensitivity or allergy to rifaximin or rifampin
  2. Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment
  3. Subject participated in an investigational drug or device study within the 30 days prior to enrollment
  4. Subject received rifaximin in a previous clinical study
  5. Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug
  6. Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug

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 ClinicalTrials.gov identifier (NCT number): NCT00328380

United States, Florida
Sunshine Medical Center
South Miami, Florida, United States, 33143
United States, Texas
Southwest Doctors, PA
Houston, Texas, United States, 77004
La Porte Family Clinic
La Porte, Texas, United States, 77571
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.

ClinicalTrials.gov Identifier: NCT00328380     History of Changes
Other Study ID Numbers: RFID3004
First Posted: May 19, 2006    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Travelers' Diarrhea
Escherichia coli
E coli
Enteroaggregative E coli
Enterotoxigenic 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