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A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.

NCT02920242 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-03-25

Study results available
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Summary

This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet.

It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The remaining 27 patients received study drug and 25 patients completed the study.

The study was terminated due to slow enrolment. The final analysis included only safety analysis in the Safety population, due to the low number of randomized patients. No efficacy analysis was performed.

Conditions

  • Travelers' Diarrhea

Interventions

DRUG

Rifaximin (Sandoz GmbH) tablet

200 mg tablet administered orally.

DRUG

Rifaximin (Xifaxan)

200 mg tablet administered orally

DRUG

Placebo

Matching Placebo tablet administered orally

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2017-05-23
Completion
2017-05-23

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02920242 on ClinicalTrials.gov