NCT00520754已完成2 期
The Efficacy and Safety of Levocetirizine Dihydrochloride Oral Drops Given 0.125 mg/kg b.i.d. During 90 Days in the Treatment of Recurrent Cough Associated With Other Allergic Symptoms, e.g. Wheezing, in Children Aged 1-2 Years.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 15
- 主要终点
- The efficacy based on daily record cards recordings
研究概览
简要总结
Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants from 2 to 24 months both inclusive
- •suffering from recurrent cough associated with other allergic symptoms
- •hospitalized for respiratory or allergy related problems
- •laboratory results within normal ranges
- •height and weight between percentile 5 and 95
排除标准
- •having taken any of the disallowed medication
- •suffering form any disorder
- •history of sleep apnea
- •having concomitant chronic disease
- •known relevant renal, hepatic, cardiac or metabolism dysfunction
- •known alcohol or drug addiction, severe psychiatric disease for the parent/guardian
结局指标
主要结局
The efficacy based on daily record cards recordings
时间窗: 90 days
次要结局
- Safety and pharmacokinetics at 90 days; skin reactivity
研究者
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