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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 23, 2017

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

Arms, Groups and Cohorts

  • Experimental: Rifaximin
    • Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
  • Active Comparator: Xifaxan
    • Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
  • Placebo Comparator: Placebo
    • Patients received placebo tablet 3 times per day for 3 days.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sandoz
  • Provider of Information About this Clinical Study
    • Sponsor

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