Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea - Full Text View

Purpose

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Rifaximin in Standard Three-Day Dosing With and Without the Antimotility Drug, Loperamide, in the Treatment of Travelers' Diarrhea

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Loperamide hydrochloride Loperamide Rifaximin

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).

Secondary Outcome Measures:

Secondary Outcome Variables:
1. Time to passage of last unformed stool - standard definition of TLUS for antibiotics (18, 20) where wellness is declared at any time during 5 days regardless of later recurrence of continuing illness during the observation period;
2. Number of unformed stools passed during two days of therapy;
3. Number of unformed stools passed during the five days of study;
4. Improvement in diarrhea (<half the number of daily entry unformed stools in 24 hours) by 24 hours and 48 hours;
5. Treatment failure defined as: a. failure to achieve wellness during five days of study (achieve a TLUS-5 d); b. Deterioration during treatment and removed from further clinical evaluation, or, c. Occurrence of a relapse after achieving wellness during
6. Occurrence of relapse during five day surveillance (occurrence of diarrhea after having a TLUS);
7. TLUS in 48 hours - last unformed stool passed during the 48 hours that loperamide is being given (rapid symptomatic improvement);
8. Number of days of moderate or severe enteric symptoms;
9. Number of days passing any number of unformed stools plus any degree (mild, moderate or severe) of daily enteric symptoms (must have both present each day);
10. Subjects global assessment of efficacy by day of study;
11. Number of hours where schedule of activities were altered because of illness;
12. Number of hours confined to bed because of diarrhea;
13. Dropped from study due to adverse reaction;
14. Number of doses of loperamide (or loperamide placebos) taken;
15. Microbiologic eradication/failure.


Estimated Enrollment:	316
Study Start Date:	June 2004
Estimated Study Completion Date:	August 2005

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 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).

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292344

Locations


Mexico
Universidad Autonoma de Guadalajara
Guadalajara, Jalisco, Mexico
University of Arizona, Colegio Guadalajara
Guadalajara, Jalisco, Mexico
University of San Diego at Iteso
Guadalajara, Jalisco, Mexico
Clinica Londres Morelos
Cuernavaca, Morelos, Mexico

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Valeant Pharmaceuticals International, Inc.

Investigators


Principal Investigator:	Herbert L. DuPont, MD	The University of Texas Health Science Center, Houston

More Information


ClinicalTrials.gov Identifier:	NCT00292344 History of Changes
Other Study ID Numbers:	TRA-04-01
Study First Received:	February 13, 2006
Last Updated:	April 17, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:


Travelers' diarrhea rifaximin loperamide enterotoxigenic E. coli

Additional relevant MeSH terms:


Diarrhea Dysentery Signs and Symptoms, Digestive Signs and Symptoms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Loperamide	Antidiarrheals Rifaximin Rifamycins Gastrointestinal Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 30, 2016