Overview

Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea

Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborators:
Bausch Health Americas, Inc.
Valeant Pharmaceuticals International, Inc.
Treatments:
Antidiarrheals
Loperamide
Rifamycins
Rifaximin
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.