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Sponsors and Collaborators: |
The University of Texas Health Science Center, Houston Salix Pharmaceuticals |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00292344 |
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) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
Condition | Intervention | Phase |
---|---|---|
Travelers' Diarrhea |
Drug: Rifaximin and loperamide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Rifaximin in Standard Three-Day Dosing With and Without the Antimotility Drug, Loperamide, in the Treatment of Travelers' Diarrhea |
Estimated Enrollment: | 316 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | August 2005 |
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 given rifaximin 200 mg three times a day for 3 days (R) (n = 102), loperamide 4 mg initially followed by 2 mg after each unformed stool not to exceed 8 mg/day for 2 days (L) (n = 104) or both drugs in the same dosage schedule (L/R) (n = 104). The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Mexico, Jalisco | |
Universidad Autonoma de Guadalajara | |
Guadalajara, Jalisco, Mexico | |
University of San Diego at Iteso | |
Guadalajara, Jalisco, Mexico | |
University of Arizona, Colegio Guadalajara | |
Guadalajara, Jalisco, Mexico | |
Mexico, Morelos | |
Clinica Londres Morelos | |
Cuernavaca, Morelos, Mexico |
Principal Investigator: | Herbert L. DuPont, MD | The University of Texas Health Science Center, Houston |
Study ID Numbers: | TRA-04-01 |
Study First Received: | February 13, 2006 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00292344 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Travelers' diarrhea rifaximin loperamide enterotoxigenic E. coli |
Protozoan Infections Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Loperamide Giardiasis Intestinal Diseases Antidiarrheals |
Signs and Symptoms Digestive System Diseases Dysentery Parasitic Diseases Rifaximin Intestinal Diseases, Parasitic Gastroenteritis |
Anti-Infective Agents Protozoan Infections Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Gastrointestinal Agents Loperamide Mastigophora Infections Giardiasis Intestinal Diseases Pharmacologic Actions |
Antidiarrheals Signs and Symptoms Digestive System Diseases Dysentery Therapeutic Uses Rifaximin Parasitic Diseases Sarcomastigophora Infections Intestinal Diseases, Parasitic Gastroenteritis |