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

Study Overview
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Brief Summary
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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.

Official 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

Conditions
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Travelers' Diarrhea

Intervention / Treatment
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* Drug: Rifaximin (Sandoz GmbH) tablet
* Drug: Rifaximin (Xifaxan)
* Drug: Placebo


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifaximin<br>Patients received Rifaximin 200 mg tablet 3 times per day for 3 days. | Drug: Rifaximin (Sandoz GmbH) tablet<br>* 200 mg tablet administered orally.<br>|
| Active Comparator: Xifaxan<br>Patients received Xifaxan 200 mg tablet 3 times per day for 3 days. | Drug: Rifaximin (Xifaxan)<br>* 200 mg tablet administered orally<br>* Other names: Xifaxan®;|
| Placebo Comparator: Placebo<br>Patients received placebo tablet 3 times per day for 3 days. | Drug: Placebo<br>* Matching Placebo tablet administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure Rate | 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. | study day 5 +/- 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Last Unformed Stool |  | within 5 study days | 
| Proportion of Patients With Clinical Failure |  | within 5 study days | 
| Proportion of Patients With Improvement of Diarrheal Syndrome |  | within 5 study days | 
| Number of Unformed Stools |  | within 5 study days | 
| The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection |  | within 5 study days | 
| Microbiological Cure Rate |  | study day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Travelers, diarrhea, rifaximin, equivalence