Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea
Condition: Diarrhea
MeSH terms: Diarrhea
Intervention: Rifaximin; Xifaxan®; Placebo Tablet
Intervention description: Tablets, generic formulation of the brand product.; Tablets, brand product.; Placebo tablets in the same image of the generic rifaximin. Has no active ingredient.
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 739.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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:

          1. 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.

          2. At least 3 unformed stools recorded within the 24 hours immediately preceding
             randomization.

          3. At least 1 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 degrees fahrenheit [°F] or ≥37.8 degrees celsius [°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, gastrointestinal (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 2 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.