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

Travelers' Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02920242
• Other study ID #: 1526 RIF_2
• Status: Terminated
• Phase: Phase 3
• Start date: December 15, 2016
• Est. completion date: May 23, 2017

Study information

• Verified date: December 2018
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: May 23, 2017
• Est. primary completion date: May 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Dysentery
• Travelers' Diarrhea

Intervention

Drug:
• Rifaximin (Sandoz GmbH) tablet
200 mg tablet administered orally.
• Rifaximin (Xifaxan)
200 mg tablet administered orally
• Placebo
Matching Placebo tablet administered orally

Locations

Country	Name	City	State
Mexico	Sandoz Investigative Site	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Last Unformed Stool		within 5 study days
Secondary	Proportion of Patients With Clinical Failure		within 5 study days
Secondary	Proportion of Patients With Improvement of Diarrheal Syndrome		within 5 study days
Secondary	Number of Unformed Stools		within 5 study days
Secondary	The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection		within 5 study days
Secondary	Microbiological Cure Rate		study day 5