NCT00968149已完成3 期
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 413
- 主要终点
- Number of Patients With Clinical Adverse Experiences (CAEs)
研究概览
简要总结
This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a history of allergic rhinitis symptoms which flare up during the study season
- •Patient is a non-smoker
- •Patient is in otherwise good health
- •Patient is able to chew a tablet
排除标准
- •Patient is hospitalized
- •Patient is pregnant or nursing mother, or <8 weeks post partum
- •Patient and/or parent intend to move or vacation away from home during the trial
- •Patient has had a major surgical procedure within 4 weeks of the prestudy visit
- •Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study
- •Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study
- •Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder
研究组 & 干预措施
1
Experimental
Montelukast
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Number of Patients With Clinical Adverse Experiences (CAEs)
时间窗: 2 weeks
A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
次要结局
- Number of Patients With Drug-related LAEs(2 weeks)
- Number of Patients With Serious CAEs(2 weeks)
- Number of Patients With Drug-related CAEs(2 weeks)
- Number of Patients Who Were Discontinued Due to CAEs(2 weeks)
- Number of Patients With Laboratory Adverse Experiences (LAEs)(2 weeks)
- Number of Patients With Serious LAEs(2 weeks)
- Number of Patients Who Were Discontinued Due to LAEs(2 weeks)
研究者
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