NCT02238223已完成不适用
Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Tablet
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
- 2,001
- 主要终点
- Incidence of adverse drug reactions
研究概览
简要总结
Study to investigate the safety and efficacy information of Alesion® Tablet under the proper use in daily clinical practice after new treatment guideline for allergic rhinitis, bronchial asthma, eczema, dermatitis, urticaria, pruritus, prurigo and psoriasis vulgaris with itching
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;
- •have at least one out of following diseases. allergic rhinitis, eczema, dermatitis, pruritus, prurigo, urticaria, psoriasis with itching, bronchial asthma
排除标准
- •Alesion® Tablet is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Tablet in package insert. However, it is unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey is drug utilization study to observe actual use in any patients. Therefore exclusion criteria is not set in the protocol
研究组 & 干预措施
Patients without experience in treatment with epinastine
干预措施: Alesion® (Drug)
结局指标
主要结局
Incidence of adverse drug reactions
时间窗: up to 24 months
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 24 months
次要结局
- Overall assessment of efficacy by investigator on a 3-point scale(after 24 months)
研究者
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