CTRI/2009/091/000934未知2 期
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 Ltd8 个研究点 分布在 1 个国家目标入组 200 人开始时间: 待定
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Duration of diarrhea: Hours from first dose of study drug until last unformed stool before diarrhea resolution.
研究概览
简要总结
The study is a randomized, double-blind, parallel group, multicentre trial comparing the safety and efficacy of different doses of Crofelemer in patients with acute infectious diarrhea.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
入选标准
- •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); orii) 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.
排除标准
- •The potential patient is a woman who is pregnant, lactating, planning a pregnancy during the study or not practicing any form of contraceptionChildren 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 diarrheaThe 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.
结局指标
主要结局
Duration of diarrhea: Hours from first dose of study drug until last unformed stool before diarrhea resolution.
时间窗: Days 1, 2 & 3
次要结局
- Improvement in enteric symptoms i.e. GIS from baseline.(Days 1, 2 & 3)
- Clinical response: Percentage of patients with Clinical success / treatment failure.(Day 3)
- Safety and tolerability(Day 3)
研究者
研究点 (8)
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