Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea
Completed · Phase 3 · Has a placebo group
Conditions studied: Diarrhea
In brief
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.
Key facts
- Study ID
- NCT02498418
- Run by
- Actavis Inc.
- People needed
- 739
- Starts
- 2016-01-06
- Expected to finish
- 2017-02-28
- Last updated by the study team
- 2019-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- At least 3 unformed stools recorded within the 24 hours immediately preceding randomization.
- At least 1 of the following signs and symptoms of enteric infection:
- abdominal pain or cramps
- nausea
- vomiting
- fecal urgency
- excessive gas/flatulence
- tenesmus
- Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.
You may not qualify if…
- Pregnant, breast feeding, or planning a pregnancy.
- Immediately prior to randomization, acute diarrhea for >72 hours.
- 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.
- 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.
- 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
- Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding. Acetaminophen (Tylenol) or paracetamol is acceptable.
Where it is running
- Site 1 — Coral Gables, Florida, United States
Full record on ClinicalTrials.gov
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