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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02920242 |
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Date of registration:
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29/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.
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Scientific title:
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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 |
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Date of first enrolment:
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December 15, 2016 |
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Target sample size:
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28 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02920242 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Mexico
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Travelers' Diarrhea
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Intervention(s)
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Drug: Rifaximin (Xifaxan)
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Drug: Placebo
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Drug: Rifaximin (Sandoz GmbH) tablet
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Primary Outcome(s)
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Clinical Cure Rate
[Time Frame: study day 5 +/- 1 day]
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Secondary Outcome(s)
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Microbiological Cure Rate
[Time Frame: study day 5]
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The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection
[Time Frame: within 5 study days]
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Proportion of Patients With Clinical Failure
[Time Frame: within 5 study days]
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Proportion of Patients With Improvement of Diarrheal Syndrome
[Time Frame: within 5 study days]
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Time to Last Unformed Stool
[Time Frame: within 5 study days]
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Number of Unformed Stools
[Time Frame: within 5 study days]
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Secondary ID(s)
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1526 RIF_2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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