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

NCT00328380 | Completed Phase 3

• 1 other identifier: RFID3004
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD) from all causes.

Conditions

Diarrhea

Keywords

Travelers' Diarrhea; Xifaxan; Rifaximin; Escherichia coli; E coli; EAEC; Enteroaggregative E coli; ETEC; Enterotoxigenic E coli

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

Rifaximin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is in good health (as determined by medical history)
• Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days
• 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)

You may not qualify if:

• Subject has hypersensitivity or allergy to rifaximin or rifampin
• Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment
• Subject participated in an investigational drug or device study within the 30 days prior to enrollment
• Subject received rifaximin in a previous clinical study
• Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug
• Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (3)

Sunshine Medical Center

South Miami, Florida, 33143, United States

Location

Southwest Doctors, PA

Houston, Texas, 77004, United States

Location

La Porte Family Clinic

La Porte, Texas, 77571, United States

Location

MeSH Terms

Conditions

Diarrhea; Escherichia coli Infections

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 19, 2006
• Study Start: December 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: September 1, 2008
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

US (3)