NCT00516737已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 主要终点
- Number of Participants Who Are Pain Free at 2 Hours Post-Dose
研究概览
简要总结
The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than one year history of migraine
- •Attacks typically mild when they begin and progress to moderate or severe
- •Experience 1-4 migraine attacks per month
排除标准
- •More than 15 headache days per month
- •Heart disease
- •Uncontrolled high blood pressure
结局指标
主要结局
Number of Participants Who Are Pain Free at 2 Hours Post-Dose
时间窗: 2 hours post-dose
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.
次要结局
- Number of Participants With Absence of Nausea at 2 Hours Post-dose(2 hours post-dose)
- Number of Participants With Absence of Phonophobia at 2 Hours Post-dose(2 hours post-dose)
- Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose(2 hours post-dose)
- Number of Participants With 24-Hour Sustained Pain Freedom(24 hours post-dose)
- Number of Participants With no Rescue Use up to 24 Hours Post-Dose(24 hours post-dose)
- Number of Participants With Absence of Photophobia at 2 Hours Post-dose(2 hours post-dose)
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