Status:
COMPLETED
Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Travelers' Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) co...
Detailed Description
During short-term study, adult U.S. students in Mexico (n = 310) with acute diarrhea (≥ 3 unformed stools with enteric symptoms) were enrolled in a double-blind, randomized trial wherein they were giv...
Eligibility Criteria
Inclusion
- Inclusion criteria include: IRB approval; signing of a consent form;18 years of age or older, providing of an unformed pre-treatment stool; females must be non-pregnant and not nursing.
Exclusion
- Exclusion criteria include: diarrhea longer than 72 hours; moderate or severe dehydration, pregnancy or breast feeding, receipt of trimethoprim-sulfamethoxazole, azalide, doxycycline, or a fluoroquinolone in the past week; unstable medical condition; hypersensitivity to rifaximin or rifampin; fever (\>100.6o F) or bloody diarrhea.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT00292344
Start Date
June 1 2004
End Date
August 1 2005
Last Update
April 20 2009
Active Locations (4)
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1
Universidad Autonoma de Guadalajara
Guadalajara, Jalisco, Mexico
2
University of Arizona, Colegio Guadalajara
Guadalajara, Jalisco, Mexico
3
University of San Diego at Iteso
Guadalajara, Jalisco, Mexico
4
Clinica Londres Morelos
Cuernavaca, Morelos, Mexico