NCT00292344

Brief Summary

Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
Last Updated

April 20, 2009

Status Verified

February 1, 2006

First QC Date

February 13, 2006

Last Update Submit

April 17, 2009

Conditions

Travelers' Diarrhea

Keywords

Travelers' diarrhearifaximinloperamideenterotoxigenic E. coli

Outcome Measures

Primary Outcomes (1)

  • The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).

Secondary Outcomes (16)

  • Secondary Outcome Variables:

  • 1. Time to passage of last unformed stool - standard definition of TLUS for antibiotics (18, 20) where wellness is declared at any time during 5 days regardless of later recurrence of continuing illness during the observation period;

  • 2. Number of unformed stools passed during two days of therapy;

  • 3. Number of unformed stools passed during the five days of study;

  • 4. Improvement in diarrhea (<half the number of daily entry unformed stools in 24 hours) by 24 hours and 48 hours;

  • +11 more secondary outcomes

Interventions

Rifaximin and loperamideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Universidad Autonoma de Guadalajara

Guadalajara, Jalisco, Mexico

Location

University of Arizona, Colegio Guadalajara

Guadalajara, Jalisco, Mexico

Location

University of San Diego at Iteso

Guadalajara, Jalisco, Mexico

Location

Clinica Londres Morelos

Cuernavaca, Morelos, Mexico

Location

MeSH Terms

Interventions

RifaximinLoperamide

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Herbert L. DuPont, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 15, 2006

Study Start

June 1, 2004

Study Completion

August 1, 2005

Last Updated

April 20, 2009

Record last verified: 2006-02

Locations

ME(4)