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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-15

Study Completion Date

2017-05-23

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.

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Detailed Description

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Conditions

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Travelers' Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rifaximin

Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.

Group Type EXPERIMENTAL

Rifaximin (Sandoz GmbH) tablet

Intervention Type DRUG

200 mg tablet administered orally.

Xifaxan

Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.

Group Type ACTIVE_COMPARATOR

Rifaximin (Xifaxan)

Intervention Type DRUG

200 mg tablet administered orally

Placebo

Patients received placebo tablet 3 times per day for 3 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo tablet administered orally

Interventions

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Rifaximin (Sandoz GmbH) tablet

200 mg tablet administered orally.

Intervention Type DRUG

Rifaximin (Xifaxan)

200 mg tablet administered orally

Intervention Type DRUG

Placebo

Matching Placebo tablet administered orally

Intervention Type DRUG

Other Intervention Names

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Xifaxan®

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No