CompletedPhase 3

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

United States739 participantsStarted 2016-01-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:
✓. 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

✕. Pregnant, breast feeding, or planning a pregnancy.
✕. Immediately prior to randomization, acute diarrhea for \>72 hours.
✕. Presence of:
✕. 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:
✕. Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding. Acetaminophen (Tylenol) or paracetamol is acceptable.

What they're measuring

Number of Participants Who Achieved Clinical Cure at Test of Cure (TOC) Visit (Within 24 to 72 Hours From the Time of Last Dose): Per-Protocol (PP) Population

Timeframe: TOC visit (Day 5, 6 or 7)

Number of Participants Who Achieved Clinical Cure at TOC Visit (Within 24 to 72 Hours From the Time of Last Dose): Modified Intent-to-Treat (mITT) Population

Timeframe: TOC visit (Day 5, 6 ,or 7)

Trial details

NCT IDNCT02498418

SponsorActavis Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02-28

Results submitted2019-11-01

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