Rifaximin for Prevention of Travellers' Diarrhea

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Diarrhea

Treatments: Drug: Rifaximin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00742469

RFID3003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Rifaximin

Treatment:

Drug: Rifaximin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo