Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Coral Gables, Florida 33134


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02498418


Primary Contact:

Study Director
Nageshwar Thudi, PhD
Actavis Inc.


Backup Contact:

N/A


Location Contact:

Coral Gables, Florida 33134
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.