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

Phase 3

Terminated

• Conditions: Travelers' Diarrhea
• Interventions: Drug: Rifaximin (Sandoz GmbH) tablet; Drug: Rifaximin (Xifaxan); Drug: Placebo

• Registration Number: NCT02920242
• Lead Sponsor: Sandoz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Study Start: 2016-12-15
• Primary Completion: 2017-05-23
• Study Completion: 2017-05-23
• Results First Submitted: 2018-04-27
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-20
• Last Update Submitted: 2018-12-20
• Results First Posted: 2019-03-25
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rifaximin	Rifaximin (Sandoz GmbH) tablet	Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
Xifaxan	Rifaximin (Xifaxan)	Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
Placebo	Placebo	Patients received placebo tablet 3 times per day for 3 days.

Primary Outcome Measures

Name	Time	Method
Clinical Cure Rate	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 Outcome Measures

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

Trial Locations

Locations (1)

Sandoz Investigative Site; 🇲🇽 Mexico City, Mexico