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

Sponsor

Bausch Health Americas, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00328380

Collaborator

(none)

660

Enrollment

Locations

Duration (Months)

220

Patients Per Site

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea	Drug: Rifaximin	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

660 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Sep 1, 2008

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunshine Medical Center	South Miami	Florida	United States	33143
2	Southwest Doctors, PA	Houston	Texas	United States	77004
3	La Porte Family Clinic	La Porte	Texas	United States	77571