NCT01986270已完成3 期
A Multicenter, Double-blind, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点目标入组 1,141 人开始时间: 1996年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,141
- 主要终点
- Headache response at 1 hour after the first dose for the first attack.
研究概览
简要总结
The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS))
- •Subjects capable of taking medication as outpatients, and recording the effects of such medication.
排除标准
- •Pregnant or breast-feeding women
- •Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Eletriptan 40 mg
Experimental
干预措施: Eletriptan 40 mg (Drug)
Eletriptan 80 mg
Experimental
干预措施: Eletriptan 80 mg (Drug)
Sumatriptan 25 mg
Experimental
干预措施: Sumatriptan 25 mg (Drug)
Sumatriptan 50 mg
Experimental
干预措施: Sumatriptan 50 mg (Drug)
结局指标
主要结局
Headache response at 1 hour after the first dose for the first attack.
时间窗: 1 hour
Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
次要结局
- Pain-free response at 1 hour after the first dose for the first attack.(1 hour)
研究者
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