Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea

Travelers' Diarrhea Clinical Trial

Official title:

Rifaximin in Standard Three-Day Dosing With and Without the Antimotility Drug, Loperamide, in the Treatment of Travelers' Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292344
• Other study ID #: TRA-04-01
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2006
• Last updated: April 17, 2009
• Start date: June 2004
• Est. completion date: August 2005

Study information

• Verified date: February 2006
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Dysentery
• Travelers' Diarrhea

Intervention

Drug:
• Rifaximin and loperamide

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).
Secondary	Secondary Outcome Variables:
Secondary	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;
Secondary	2. Number of unformed stools passed during two days of therapy;
Secondary	3. Number of unformed stools passed during the five days of study;
Secondary	4. Improvement in diarrhea (<half the number of daily entry unformed stools in 24 hours) by 24 hours and 48 hours;
Secondary	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
Secondary	6. Occurrence of relapse during five day surveillance (occurrence of diarrhea after having a TLUS);
Secondary	7. TLUS in 48 hours - last unformed stool passed during the 48 hours that loperamide is being given (rapid symptomatic improvement);
Secondary	8. Number of days of moderate or severe enteric symptoms;
Secondary	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);
Secondary	10. Subjects global assessment of efficacy by day of study;
Secondary	11. Number of hours where schedule of activities were altered because of illness;
Secondary	12. Number of hours confined to bed because of diarrhea;
Secondary	13. Dropped from study due to adverse reaction;
Secondary	14. Number of doses of loperamide (or loperamide placebos) taken;
Secondary	15. Microbiologic eradication/failure.