Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00328380
• Date of registration: 17/05/2006
• Primary sponsor: Salix Pharmaceuticals
• Public title: Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety of Rifaximin for the Prevention of Travelers' Diarrhea in Subjects Traveling Outside the United States
• Date of first enrolment: December 2005
• Target sample size: 660
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00328380
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject is in good health (as determined by medical history)

2. Subject is planning on traveling anywhere outside the US (except Canada) for at least
5 and no more than 14 days

3. Subject is scheduled to depart on their planned trip no later than 14 days and no
earlier than 4 days after having blood drawn for clinical laboratory assessments and
urine collected for a pregnancy test (females of childbearing potential only)

Exclusion Criteria:

1. Subject has hypersensitivity or allergy to rifaximin or rifampin

2. Subject has known or suspected alcohol abuse or illicit drug use within 1 year of
enrollment

3. Subject participated in an investigational drug or device study within the 30 days
prior to enrollment

4. Subject received rifaximin in a previous clinical study

5. Subject received any systemic or gastrointestinal-specific antibiotic within 7 days
of the first dose of study drug

6. Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS,
Kaopectate®) within 24 hours of the first dose of study drug



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diarrhea

Intervention(s)

Drug: Rifaximin

Primary Outcome(s)

The primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo.

Secondary Outcome(s)

A secondary endpoints of this study include assessment of the differences between the 2 treatment groups based upon the proportion of subjects with TD during the 14-day Treatment Period.

Secondary ID(s)

RFID3004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors