Drug Use Investigation for IMIGRAN Tablet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,571
- 主要终点
- The number of incidence of adverse events in subjects with migraine disorders
研究概览
简要总结
The study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study.
A special focus was placed on the investigation of occurrence of "ischaemic heart disease-like events including arrhythmia, angina pectoris, and myocardial infarction" in the present study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with migraine disorders
排除标准
- •Subjects with hypersensitivity to sumatriptan
- •Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
- •Subjects with history of peripheral vascular disorder
- •Subjects with history of cerebrovascular disorder or transient ischemic attacks
- •Subjects with uncontrolled high-blood pressure
- •Subjects with severe hepatic function disorder
- •Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
- •Subjects taking monoamine oxidaze inhibitor or use within 2 weeks of discontinuation
研究组 & 干预措施
Subjects prescribed IMIGRAN
Subjects with migraine disorders prescribed IMIGRAN during study period
干预措施: Sumatriptan (Drug)
结局指标
主要结局
The number of incidence of adverse events in subjects with migraine disorders
时间窗: 2 months
Adverse event (AE), diagnosis or symptom, date of onset, outcome, date of outcome, seriousness, reason for judgement of "serious", intensity, relationship to IMIGRAN, other factors suspected to have relationship to AE
次要结局
- Occurrence of angina pectoris(2 months)
- Occurrence of arrhythmia(2 months)
- Occurrence of myocardial infarction(2 months)