A Randomized, Double-Blind, Parallel Group, Active and Placebo-controlled,Therapeutic Equivalence Trial of Rifaximin 200 mg and Xifaxan® 200 mg in Patientswith Travelers’ Diarrhea.

Not Applicable

• Conditions: -A09 Diarrhoea and gastroenteritis of presumed infectious origin; Diarrhoea and gastroenteritis of presumed infectious origin; A09

• Registration Number: PER-010-16
• Lead Sponsor: Alvogen Pine Brook, LLC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Patient is able to read and understand the language of the informed consent and Patient
eDiary
2. Patient has signed an informed consent form
3. Adult male or non-pregnant female aged ≥ 18 years
4. International travelers (e.g. visiting students / faculty or international tourists) who
arrived from their country of residence within 30 days of the Screening and
Randomization visit
5. Affected by naturally acquired acute diarrhea, defined as the passage of at least three
unformed stools within the 24 hours immediately preceding randomization (see Section
11.2.1 for definition of unformed and formed stools)
6. At least one of the following signs and symptoms of enteric infection within the 24 hours
immediately preceding randomization:
• Abdominal pain or cramps
• Nausea
• Vomiting
• Fecal urgency
• Excessive gas/flatulence
• Tenesmus

Exclusion Criteria

1. Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the
excipients of the study medication
2. Presence of a medical condition with regular GI symptoms, e.g. Crohn’s disease,
ulcerative colitis, indeterminate colitis, previous bowel surgery which impacts absorption
long term, thyrotoxicosis, short bowel syndrome
3. Patient requires medication which alters GI function
4. Patient requires use of long term antibiotics (e.g. urinary tract infection prophylaxis, acne)
5. Pregnant, breast feeding, or planning a pregnancy
6. Immediately prior to randomization, acute diarrhea for > 72 hours
7. Presence of:
• Fever (≥ 100 °F or ≥ 37.8 °C), or
• Hematochezia (blood in stool), or
• Clinical findings suggesting moderate or severe dehydration

Study & Design

• Study Type: Interventional
• Study Design: Not specified