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



Status:Completed
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:6/28/2017
Start Date:June 2016
End Date:February 2017

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A Randomized, Double-Blind, Parallel, Multicenter, Bioequivalence Study Comparing Rifaximin 200-mg Tablets With Xifaxan® 200-mg Tablets and With Placebo in the Treatment of Traveler's Diarrhea

The primary objective is to demonstrate rifaximin 200-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 subjects with travelers' diarrhea.

This is a randomized, placebo-controlled bioequivalent study with a clinical endpoint in the
treatment of travelers' diarrhea. After three unformed stools are recorded within the 24
hours immediately preceding randomization, subjects are to be randomized to receive the
generic rifaximin 200 mg oral tablet, the reference listed drug (RLD) 200 mg oral tablet or
placebo three times daily for 3 days (i.e., on study Days 1, 2, and 3). The primary endpoint
is clinical cure at the test of cure (TOC) visit on study Day 5.

Inclusion Criteria:

1. Adult male or nonpregnant female aged ≥ 18 years non-indigenous travelers (e.g.,
visiting students/faculty or international tourists) affected by naturally acquired
acute diarrhea. Diarrhea is defined as the passage of at least three 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 three unformed stools recorded within the 24 hours immediately preceding
randomization.

3. At least one 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 °F or ≥ 37.8 °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, 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 two 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.

7. If required during the study antimalarial prophylactic treatment, including
doxycycline, is permitted prior to and during the study
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Coral Gables, FL
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