临床试验/NCT01332383

NCT01332383已完成不适用

Special Drug Use Investigation for AMERGE Tablet (Long-term)

GlaxoSmithKline0 个研究点目标入组 300 人开始时间: 2009年5月最近更新: 2015年8月13日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 300
主要终点: The number of adverse drug reactions and serious adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Must use AMERGE for the first time

排除标准

•Patients with hypersensitivity to naratriptan or any of the components.
•Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa
•Patients with history of cerebral vascular disturbance or transient ischaemic attack
•Patients with peripheral vascular syndromes
•Patients with uncontrolled hypertension
•Patients with severe renal or hepatic impairment
•Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or ergot-type medication

研究组 & 干预措施

Patients prescribed AMERGE

Patients with migraine disorders prescribed AMERGE during study period

干预措施: Naratriptan (Drug)

结局指标

主要结局

The number of adverse drug reactions and serious adverse events

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

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