Clinical trial NCT00328380: Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea
Keywords: Travelers' Diarrhea
Xifaxan
Rifaximin
Escherichia coli
E coli
EAEC
Enteroaggregative E coli
ETEC
Enterotoxigenic E coli
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-19
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Travelers' diarrhea (TD) is the most common illness in travelers to the developing world, occurring in 60% or more of international travelers to high-risk areas. It can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans. Findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness. Specifically, persistent diarrhea has been reported in 2% to 10% of travelers developing diarrhea. Moreover, bacterial enterocolitis, including that associated with TD, leads to post-infectious irritable bowel syndrome in 4% to 31% of patients.

Eligibility 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

Primary outcomes:
measure: The primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo.
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Sunshine Medical Center
state: Florida
city: Houston
country: United States
facility: Southwest Doctors, PA
state: Texas
city: La Porte
country: United States
facility: La Porte Family Clinic
state: Texas
Study officials:
References: