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Rifaximin for Prevention of Travellers' Diarrhea

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00742469
First received: August 24, 2008
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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

Further study details as provided by Salix Pharmaceuticals:

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 ] [ Designated as safety issue: No ]

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
Rifaximin
 Drug: Rifaximin
Placebo Comparator: 2
Placebo
 Drug: Placebo

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742469

Locations
Mexico
University of San Diego
Guadalajara, Jalisco, Mexico, 45090
Sponsors and Collaborators
Salix Pharmaceuticals
  More Information

No publications provided by Salix Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: William Forbes, Pharm.D., Salix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00742469     History of Changes
Other Study ID Numbers: RFID3003
Study First Received: August 24, 2008
Last Updated: December 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
TD
traveller's diarrhea
campylobacter
shigella
 salmonella
E. coli
diarrhea

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