NCT00310453已完成1 期
A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of ALK Grass Tablet in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Assessment of safety by recording of adverse events
研究概览
简要总结
The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grass pollen induced rhinoconjunctivitis
- •Boys and girls, 5-12 years of age
- •Positive skin prick test to grass pollen
排除标准
- •Severe asthma
- •Previous treatment with immunotherapy
结局指标
主要结局
Assessment of safety by recording of adverse events
次要结局
未报告次要终点
研究者
研究点 (2)
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