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Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea

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.
 
ClinicalTrials.gov Identifier: NCT00292344
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : April 20, 2009
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by:
The University of Texas Health Science Center, Houston

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) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.

Condition or disease Intervention/treatment Phase
Travelers' Diarrhea Drug: Rifaximin and loperamide Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 316 participants
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
Study Start Date : June 2004
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea




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

Secondary Outcome Measures :
  1. Secondary Outcome Variables:
  2. 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;
  3. 2. Number of unformed stools passed during two days of therapy;
  4. 3. Number of unformed stools passed during the five days of study;
  5. 4. Improvement in diarrhea (<half the number of daily entry unformed stools in 24 hours) by 24 hours and 48 hours;
  6. 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
  7. 6. Occurrence of relapse during five day surveillance (occurrence of diarrhea after having a TLUS);
  8. 7. TLUS in 48 hours - last unformed stool passed during the 48 hours that loperamide is being given (rapid symptomatic improvement);
  9. 8. Number of days of moderate or severe enteric symptoms;
  10. 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);
  11. 10. Subjects global assessment of efficacy by day of study;
  12. 11. Number of hours where schedule of activities were altered because of illness;
  13. 12. Number of hours confined to bed because of diarrhea;
  14. 13. Dropped from study due to adverse reaction;
  15. 14. Number of doses of loperamide (or loperamide placebos) taken;
  16. 15. Microbiologic eradication/failure.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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
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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
Bausch Health Americas, Inc.
Investigators
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Principal Investigator: Herbert L. DuPont, MD The University of Texas Health Science Center, Houston
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ClinicalTrials.gov Identifier: NCT00292344    
Other Study ID Numbers: TRA-04-01
First Posted: February 15, 2006    Key Record Dates
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:
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Dysentery
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Rifaximin
Loperamide
Antidiarrheals
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents