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

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00328380
First received: May 17, 2006
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Diarrhea
 Drug: Rifaximin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Drug Information available for: Rifaximin
U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 660
Study Start Date: December 2005
Study Completion Date: September 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328380

Locations
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
Salix Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00328380     History of Changes
Other Study ID Numbers: RFID3004
Study First Received: May 17, 2006
Last Updated: December 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Travelers' Diarrhea
Xifaxan
Rifaximin
Escherichia coli
E coli
 EAEC
Enteroaggregative E coli
ETEC
Enterotoxigenic E coli

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 17, 2013