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

Phase 3TerminatedNCT02920242

Sandoz28 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Travelers' Diarrhea

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: study day 5 +/- 1 day