Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea

NCT ID: NCT02498418

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 739 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-06
• Study Completion Date: 2017-02-28

Brief Summary

The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day (TID) for 3 days in participants with travelers' diarrhea.

Detailed Description

This is a randomized, placebo-controlled bioequivalent study with a clinical endpoint in the treatment of travelers' diarrhea. After 3 unformed stools are recorded within the 24 hours immediately preceding randomization, participants are to be randomized to receive the generic rifaximin 200 mg oral tablet, Xifaxan (the reference listed drug)200 mg oral tablet, or placebo 3 times daily for 3 days (that is; on Days 1, 2, and 3).

Conditions

Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Generic Rifaximin 200 mg Tablets

Participants will receive a generic rifaximin 200 mg tablet 3 times daily orally for 3 days.

Group Type: EXPERIMENTAL

Rifaximin

Intervention Type: DRUG

Tablets, generic formulation of the brand product.

Xifaxan 200 mg Tablets

Participants will receive a xifaxan 200 mg tablet 3 times daily orally for 3 days.

Group Type: ACTIVE_COMPARATOR

Xifaxan®

Intervention Type: DRUG

Tablets, brand product.

Placebo

Participants will receive a rifaximin placebo tablet 3 times daily orally for 3 days.

Group Type: PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type: DRUG

Placebo tablets in the same image of the generic rifaximin. Has no active ingredient.

Interventions

Rifaximin

Tablets, generic formulation of the brand product.

Intervention Type: DRUG

Xifaxan®

Tablets, brand product.

Intervention Type: DRUG

Placebo Tablet

Placebo tablets in the same image of the generic rifaximin. Has no active ingredient.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adult male or nonpregnant female aged ≥18 years non-indigenous travelers (for example; visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. Diarrhea is defined as the passage of at least 3 unformed stools in a 24-hour period. Stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). When using this classification, both soft and watery stools are unformed and abnormal.

2. At least 3 unformed stools recorded within the 24 hours immediately preceding randomization.

3. At least 1 of the following signs and symptoms of enteric infection:

• abdominal pain or cramps
• nausea
• vomiting
• fecal urgency
• excessive gas/flatulence
• tenesmus

4. Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.

Exclusion Criteria

1. Pregnant, breast feeding, or planning a pregnancy.

2. Immediately prior to randomization, acute diarrhea for >72 hours.

3. Presence of:

• fever (≥100 degrees fahrenheit [°F] or ≥37.8 degrees celsius [°C]), or
• hematochezia (blood in stool), or
• clinical findings suggesting moderate or severe dehydration.

4. Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, gastrointestinal (GI) tract (other than infectious diarrhea in travelers), or central nervous system.

5. Administration of any of the following:

• any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization
• more than 2 doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization

6. Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding. Acetaminophen (Tylenol) or paracetamol is acceptable.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Actavis Inc.

Locations

Site 1

Coral Gables, Florida, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

ACTA/RIFX/2015

Identifier Type: -

Identifier Source: org_study_id