A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.
December 20, 2018 updated by: Sandoz
A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center, Therapeutic Equivalence Study to Compare Rifaximin 200 mg Tablets (Sandoz GmbH) to Xifaxan® 200 mg Tablets (Salix Pharmaceuticals, Inc.) and Placebo in Patients With Travelers' Diarrhea
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mexico City, Mexico
- Sandoz Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient is able to read and understood the language of the Informed Consent Form and Patient Information.
- International travelers with a duration of stay in host country long enough to attend schedules visits.
- Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization
Exclusion Criteria:
- Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug.
- Pregnant, breast feeding or planning pregnancy
- Acute diarrhea for > 72 hours immediately prior to randomization.
- Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rifaximin
Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
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200 mg tablet administered orally.
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Active Comparator: Xifaxan
Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
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200 mg tablet administered orally
Other Names:
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Placebo Comparator: Placebo
Patients received placebo tablet 3 times per day for 3 days.
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Matching Placebo tablet administered orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Cure Rate
Time Frame: study day 5 +/- 1 day
|
Clinical cure was defined as either no stools or only formed stools within a 48 hour period and no fever, with or without other enteric symptoms, OR no watery stools or no more than two soft stools passed within a 24 hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence.
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study day 5 +/- 1 day
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to Last Unformed Stool
Time Frame: within 5 study days
|
within 5 study days
|
|
Proportion of Patients With Clinical Failure
Time Frame: within 5 study days
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within 5 study days
|
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Proportion of Patients With Improvement of Diarrheal Syndrome
Time Frame: within 5 study days
|
within 5 study days
|
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Number of Unformed Stools
Time Frame: within 5 study days
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within 5 study days
|
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The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection
Time Frame: within 5 study days
|
within 5 study days
|
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Microbiological Cure Rate
Time Frame: study day 5
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study day 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2016
Primary Completion (Actual)
May 23, 2017
Study Completion (Actual)
May 23, 2017
Study Registration Dates
First Submitted
September 29, 2016
First Submitted That Met QC Criteria
September 29, 2016
First Posted (Estimate)
September 30, 2016
Study Record Updates
Last Update Posted (Actual)
March 25, 2019
Last Update Submitted That Met QC Criteria
December 20, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1526 RIF_2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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