Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate

Organon and Co0 个研究点目标入组 188 人开始时间: 2003年9月25日最近更新: 2024年8月15日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Organon and Co
入组人数: 188
主要终点: Improvement of morning peak expiratory flow over first 2 weeks

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to < 15.

The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 6 Years 至 14 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Intermittent asthma, mild persistent asthma, moderate persistent asthma, or severe persistent asthma patients with 2 or more mild or moderate attacks at baseline

排除标准

•Patient using anti-asthma treatment or therapy including corticosteroids or oral anti-allergic drugs
•Patient with complications that will impair the judgment of efficacy of this drug
•Patient with convulsive disorders such as epilepsy or such a history
•Patient with liver disease, renal impairment, heart disease or such other complication

结局指标

主要结局

Improvement of morning peak expiratory flow over first 2 weeks

次要结局

未报告次要终点

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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