Phase 3
N=739
Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea
Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT02498418 ↗Enrolled (actual)
739
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: 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 — 90; 93 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rifaximin (Drug); Xifaxan® (Drug); Placebo Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actavis Inc.
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
90; 93 | — |
| PRIMARY 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 |
91; 95; 86 | 0.7899 |
| SECONDARY Time to Last Unformed Stool (TLUS) |
65.25; 65.75; 67.01 | — |
| SECONDARY Percentage of Participants Who Achieved Microbiological Cure at TOC Visit (Within 24 to 72 Hours From the Time of Last Dose) |
25.5; 31.9; 17.4; 43.5; 54.5; 68.4 | — |
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.
Eligibility Criteria
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:
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02498418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.