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.

Alvogen Pine Brook, LLC,0 个研究点目标入组 0 人开始时间: 2016年9月29日最近更新: 2023年9月4日

试验速览

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•1. Patient is able to read and understand the language of the informed consent and Patient
•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
•Fecal urgency
•Excessive gas/flatulence

•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

发起方

Alvogen Pine Brook, LLC,