Back to resultsRifaximin for Prevention of Travellers' Diarrhea
Primary Purpose
Diarrhea
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Rifaximin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhea focused on measuring TD, traveller's diarrhea, campylobacter, shigella, salmonella, E. coli, diarrhea
Eligibility Criteria
Inclusion Criteria:
- travelling to Mexico within 72 hours of enrollment
- read and understand English
- in good health
Exclusion Criteria:
- 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.
Sites / Locations
- University of San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Rifaximin
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00742469
First Posted
August 24, 2008
Last Updated
December 3, 2019
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00742469
Brief Title
Rifaximin for Prevention of Travellers' Diarrhea
Official Title
A Randomized,Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Rifaximin for the Prevention of Travellers' Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
TD, traveller's diarrhea, campylobacter, shigella, salmonella, E. coli, diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Rifaximin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment
Description
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.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
travelling to Mexico within 72 hours of enrollment
read and understand English
in good health
Exclusion Criteria:
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.
Facility Information:
Facility Name
University of San Diego
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45090
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
20412178
Citation
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.
Results Reference
derived
Learn more about this trial
Rifaximin for Prevention of Travellers' Diarrhea
We'll reach out to this number within 24 hrs