A Double-Blind, Randomized, Four Arm, Dose Ranging (Phase IIb) Study to Assess the Efficacy, Safety and Tolerability of Crofelemer in the Treatment of Adult Acute Infectious Diarrhea

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Age: 18 to 65 years.
•Adult male and female patients with acute diarrhea defined as the occurrence of three or more unformed stools (soft or watery consistency) within the 24 hour period preceding entry into the study.
•Potential female patients are of:i) Non-childbearing potential (e.g., physiologically incapable of becoming pregnant, including surgically sterile or post-menopausal women); or
•ii) Childbearing potential with a negative pregnancy test at the screening/baseline visit and using an acceptable contraceptive method approved by the investigator. [Any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician.]
•Up to 1.5 L of IV fluid acceptable
•Written Informed Consent & Patient willing to follow up.

•The potential patient is a woman who is pregnant, lactating, planning a pregnancy during the study or not practicing any form of contraception
•Children or adolescent females less than 18 years age.
•Patients who develop hypersensitivity to crofelemer /placebo after dosing.
•Patients with chronic, iatrogenic, or bloody diarrhea with fever > 390C.
•Patients with severe dehydration, requiring IV fluids &/or antibiotics.
•Patients with HIV associated diarrhea
•The potential patient has a history of receiving antimicrobial or antidiarrheal medication [e.g. kaolin, pectin, cholestyramine, racecadotril and opioid classes of drugs (loperamide, lomotil, etc.)] within 48 hours prior to admission.
•Patients with significant cardiac, hepatic, renal, diabetic or cerebrovascular disease, or other serious illness.
•Any condition which is likely to hamper compliance of the patient with the study protocol or unwilling to maintain their daily dairy.
•The potential patient is unwilling or unable to take part in this study.
•Participated in a new drug study in past 3 months.

发起方

Glenmark Pharmaceuticals Ltd