Rifaximin for Prevention of Travellers' Diarrhea

This study has been completed.
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00742469
First received: August 24, 2008
Last updated: December 21, 2009
Last verified: December 2009
  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:


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 ] [ 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   (Adult, Senior)
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
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, see Learn About Clinical Studies.

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

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

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 Valeant Pharmaceuticals International, Inc.:
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
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 26, 2016