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Rifaximin for Prevention of Travellers' Diarrhea

NCT ID: NCT00742469

Last Updated: 2019-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-04-30

Brief Summary

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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

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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.

Conditions

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Diarrhea

Keywords

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TD traveller's diarrhea campylobacter shigella salmonella E. coli diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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1

Rifaximin

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Rifaximin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of San Diego

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type DERIVED
PMID: 20412178 (View on PubMed)

Other Identifiers

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RFID3003

Identifier Type: -

Identifier Source: org_study_id