Rifaximin for Prevention of Travellers' Diarrhea

Diarrhea Clinical Trial

Official title:

A Randomized,Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Rifaximin for the Prevention of Travellers' Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742469
• Other study ID #: RFID3003
• Status: Completed
• Phase: Phase 3
• Start date: June 2005
• Est. completion date: April 2007

Study information

• Verified date: December 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Description:

To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 2007
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. travelling to Mexico within 72 hours of enrollment

2. read and understand English

3. in good health

Exclusion Criteria:

1. acute diarrhea within previous 7 days

2. taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.

3. taken antidiarrheal medication within 24 hours of enrollment or anytime during study.

Related Conditions & MeSH terms

• Diarrhea

Intervention

Drug:
• Rifaximin

• Placebo

Locations

Country	Name	City	State
Mexico	University of San Diego	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment	The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes.	14 days