A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Examine the Safety, Tolerability, and Efficacy of Single Oral Doses of MK0462 5 mg, MK0462 10 mg, and Sumatriptan 100 mg for Acute Treatment of Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,268
- 主要终点
- Time to Relief Within 2 Hours After Dose
研究概览
简要总结
A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of 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
- •Patient had at least a 6-month history of migraine, with or without aura
- •Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
- •Patient was judged to be in good health, apart from migraine
排除标准
- •Patient was pregnant or a nursing mother
- •Patient had abused drugs or alcohol within 12 months prior to entering the study
- •Patient had a history of cardiovascular disease
- •Patient had clinically significant Electrocardiography (ECG) abnormality
- •Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
- •Patient received treatment with an investigational device or compound within 30 days of the study start
- •Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
- •Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
- •Patient had hypersensitivity to sumatriptan
- •Patient had participated in any previous study involving rizatriptan
研究组 & 干预措施
1
rizatriptan 5 mg
干预措施: rizatriptan benzoate (Drug)
2
rizatriptan 10 mg
干预措施: rizatriptan benzoate (Drug)
结局指标
主要结局
Time to Relief Within 2 Hours After Dose
时间窗: within 2 hours after dose
Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose
Pain Relief at 2 Hours After Dose
时间窗: 2 hours after dose
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
次要结局
- Pain Free at 2 Hours After Dose(2 hours after dose)
- Functional Status at 2 Hours After Dose(2 hours after dose)
- Nausea at 2 Hours After Dose(2 hours after dose)