Rifaximin for Prevention of Travellers' Diarrhea
A Randomized,Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Rifaximin for the Prevention of Travellers' Diarrhea
1 other identifier
interventional
210
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 24, 2008
CompletedFirst Posted
Study publicly available on registry
August 27, 2008
CompletedResults Posted
Study results publicly available
December 18, 2019
CompletedDecember 18, 2019
December 1, 2019
3 months
August 24, 2008
December 8, 2017
December 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
1
ACTIVE COMPARATORRifaximin
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- travelling to Mexico within 72 hours of enrollment
- read and understand English
- in good health
You may not qualify if:
- acute diarrhea within previous 7 days
- taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study.
- taken antidiarrheal medication within 24 hours of enrollment or anytime during study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of San Diego
Guadalajara, Jalisco, 45090, Mexico
Related Publications (1)
Martinez-Sandoval F, Ericsson CD, Jiang ZD, Okhuysen PC, Romero JH, Hernandez N, Forbes WP, Shaw A, Bortey E, DuPont HL. Prevention of travelers' diarrhea with rifaximin in US travelers to Mexico. J Travel Med. 2010 Mar-Apr;17(2):111-7. doi: 10.1111/j.1708-8305.2009.00385.x.
PMID: 20412178DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Valeant Pharmaceuticals
- Organization
- Valeant Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2008
First Posted
August 27, 2008
Study Start
June 1, 2005
Primary Completion
September 1, 2005
Study Completion
April 1, 2007
Last Updated
December 18, 2019
Results First Posted
December 18, 2019
Record last verified: 2019-12