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

November 21, 2019 updated by: Bausch Health Americas, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

660

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • Sunshine Medical Center
    • Texas
      • Houston, Texas, United States, 77004
        • Southwest Doctors, PA
      • La Porte, Texas, United States, 77571
        • La Porte Family Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

May 17, 2006

First Submitted That Met QC Criteria

May 17, 2006

First Posted (Estimate)

May 19, 2006

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFID3004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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