NCT00632385已完成4 期
An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2003年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Change from baseline in headache pain severity
研究概览
简要总结
To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of migraine headache according to International Headache Society criteria and migraine headaches for at least 1 year
- •Eletriptan naive
- •Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months
排除标准
- •Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks
- •Migraine attacks that are atypical or chronic daily headaches
- •A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura
研究组 & 干预措施
A
Experimental
干预措施: Eletriptan (Drug)
结局指标
主要结局
Change from baseline in headache pain severity
时间窗: 1, 2, 4, and 24 hours
次要结局
- Subject Preference Questionnaire(Week 10)
- Physical examination(Week 10)
- Functional impairment(1, 2, 4, and 24 hours)
- Global Evaluation(Week 10)
- Subject Satisfaction Scale(Week 10)
- Associated Symptoms(1, 2, 4, and 24 hours)
- Work Productivity Questionnaire(Week 10)
- Use of Rescue Medication(Week 10)
- Time Loss(Week 10)
- Vital signs(Week 10)
- Adverse events(Week 10)
研究者
研究点 (1)
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