Back to resultsPrevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
Primary Purpose
Diarrhea
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhea focused on measuring Travelers' Diarrhea, Xifaxan, Rifaximin, Escherichia coli, E coli, EAEC, Enteroaggregative E coli, ETEC, Enterotoxigenic E coli
Eligibility Criteria
Inclusion Criteria: Subject is in good health (as determined by medical history) Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days 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: Subject has hypersensitivity or allergy to rifaximin or rifampin Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment Subject participated in an investigational drug or device study within the 30 days prior to enrollment Subject received rifaximin in a previous clinical study Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug
Sites / Locations
- Sunshine Medical Center
- Southwest Doctors, PA
- La Porte Family Clinic
Outcomes
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.
Full Information
NCT ID
NCT00328380
First Posted
May 17, 2006
Last Updated
November 21, 2019
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00328380
Brief Title
Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
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 Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
Travelers' Diarrhea, Xifaxan, Rifaximin, Escherichia coli, E coli, EAEC, Enteroaggregative E coli, ETEC, Enterotoxigenic E coli
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
660 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Primary Outcome Measure Information:
Title
The primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is in good health (as determined by medical history)
Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days
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:
Subject has hypersensitivity or allergy to rifaximin or rifampin
Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment
Subject participated in an investigational drug or device study within the 30 days prior to enrollment
Subject received rifaximin in a previous clinical study
Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug
Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug
Facility Information:
Facility Name
Sunshine Medical Center
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Southwest Doctors, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
La Porte Family Clinic
City
La Porte
State/Province
Texas
ZIP/Postal Code
77571
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
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