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

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 acquiredacute 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 shapeof container), or watery (can be poured). When using this classification, both softand watery stools are unformed and abnormal.

2. At least 3 unformed stools recorded within the 24 hours immediately precedingrandomization.

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 beginningtherapy 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 intravelers), or central nervous system.

5. Administration of any of the following:

• any antimicrobial agents with an expected activity against enteric bacterialpathogens within 7 days preceding randomization

• more than 2 doses of a symptomatic antidiarrheal compound such as antimotilityagents, absorbent agents, and antisecretory agents within 8 hours precedingrandomization

6. Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding.Acetaminophen (Tylenol) or paracetamol is acceptable.