Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: DuPont, Hurbert L., MD
• Collaborators: Bausch Health Americas, Inc.; The University of Texas Health Science Center, Houston; Valeant Pharmaceuticals International, Inc.
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• An Investigational Review Board approved, written informed consent is appropriately witnessed, signed and dated prior to any study-related activities

• Male or female subjects 18 years of age or older

• Able to read and understand English

• Enrolled and started on prophylaxis within 72 hours of arrival in Mexico

• If the subject is female, only women with non-childbearing potential or those who are not pregnant will be eligible. Urine pregnancy tests will be performed on those women who question their pregnancy status. Women on the study are required to employ a reliable method of contraception while taking medication. Forms of acceptable contraception include:

• Double barrier method of contraception.

• Oral birth control pills for at least two cycles before enrollment and continuing during therapy - subjects will be told they should use a barrier contraception method during the study as well.

• Norplant inserted at least one month before enrollment.

• An intrauterine device inserted by a qualified clinician.

• Medroxyprogesterone acetate for a minimum of one month before study and administered for one month following study completion.

• An approved birth control patch for at least two cycles before enrollment and continuing during therapy. OR

• Complete abstinence from intercourse for the two weeks of medication.

Exclusion Criteria:

• Acute diarrhea (criteria for travelers' diarrhea above) within the past week

• Diarrhea developing within 24 hours of study enrollment

• In Mexico for more than 72 hours

• Receipt of one of the following classes of drugs: fluoroquinolone (any drug in class), macrolide or azalide or trimethoprim-sulfamethoxazole within the past week or during the three week study

• Receipt of other medication to decrease the occurrence of diarrhea (e.g. bismuth subsalicylate or lactobacillus preparations)

• For females, pregnancy or breast feeding during the three week study

• Receipt of antidiarrheal medication (loperamide, bismuth subsalicylate, kaopectate) within 24 hours of enrollment

• Hypersensitivity to rifaximin

• Unstable medical condition including chronic renal failure and insulin dependent diabetes.