jRCT2031240403招募中不适用
TK-042 Phase III Clinical Study A Double-blind, Parallel-group Phase III Study in Pediatric patients with Chronic Urticaria
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 7age old over 至 12age old not（—）
- 性别
- All
入选标准
- •>= 7 to < 12 years of age.
- •Chronic urticaria for over 6 weeks
排除标准
- •With the primary diagnosis of stimulus-inducible urticaria (e.g. physical urticaria [cold , solar or heat, etc.], cholinergic urticaria, and contact urticaria).
- •Have concominant skin disorders which Principal/sub-investigator judges to afffect the efficacy evaluation.
- •With uncontrolled mild to moderate bronchial asthma (those who require injectable, oral, or inhaled steroid medications), or with severe bronchial asthma.
- •Have history of hypersensitivity to antihistamine drugs or any ingredients of investigational drugs.
- •Currently undergoing allergen immunotherapy such as sublingual immunotherapy or have undergone such therapy within the past 3 years prior to screening.
- •Have severe hepatobiliary disorders.
- •Have severe renal or urinary disorders.
结局指标
主要结局
-
Change from baseline in UAS7(Urticaria Actively Score 7)
次要结局
未报告次要终点
研究者
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