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Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292344
First Posted: February 15, 2006
Last Update Posted: April 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by:
The University of Texas Health Science Center, Houston
  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
Intervention Model: Single Group Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 13, 2006
First Posted: February 15, 2006
Last Update Posted: April 20, 2009
Last Verified: February 2006

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
Rifaximin
Rifamycins
Loperamide
Antidiarrheals
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents