NCT02238249已完成不适用
Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Special Drug Use-Results Survey of Alesion® Dry Syrup-
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Incidence of adverse drug reactions
研究概览
简要总结
Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with urticaria
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients who:
- •haven't treatment experience of epinastine product entered the survey;
- •have urticaria
排除标准
- •Alesion® Dry Syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Dry Syrup in package insert. However, it was unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey was drug utilization study to observe actual use in any patients. Therefore exclusion criteria are not set in the protocol
研究组 & 干预措施
paediatric patients with urticaria
干预措施: Alesion® (Drug)
结局指标
主要结局
Incidence of adverse drug reactions
时间窗: up to 2 years
classified by Medical Dictionary for Regulatory Activities (MedDRA)
Incidence of adverse drug reactions classified by patient's background/treatment factors
时间窗: up to 2 years
次要结局
- Overall assessment of efficacy by investigator on a 3-point scale(after 1 week)
研究者
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