A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK0974 Co-administered With Ibuprofen or Acetaminophen in Patients With Migraine With or Without Aura
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 683
- 主要终点
- Percentage of Participants With Pain Freedom at Two Hours Post-dose
研究概览
简要总结
This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines.
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
- •Must be 18 years of age or older
- •History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study
- •Willing to stay awake for at least 2 hours after taking study drug
- •Able to read, understand and complete questionnaires and diaries
排除标准
- •Breast-feeding, pregnant, or plan to become pregnant during the study
- •Not able to tell migraine attack from other headaches
- •Older than 50 years of age at migraine onset
- •Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study
- •History of gastric or small intestinal surgery
- •History of heart attack, stroke, unstable angina, coronary artery bypass surgery or transient ischemic attack in the 3 months before starting in the study
- •Currently participating or have participated in a study with in investigational compound or device in the last 30 days
研究组 & 干预措施
Placebo
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
干预措施: placebo (Drug)
Telcagepant 280 mg +Ibuprofen 400 mg
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
干预措施: ibuprofen (Drug)
Telcagepant 280 mg +Ibuprofen 400 mg
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
干预措施: telcagepant (Drug)
Telcagepant 280 mg +APAP 1000 mg
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
干预措施: acetominophen (Drug)
Telcagepant 280 mg +APAP 1000 mg
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
干预措施: telcagepant (Drug)
Telcagepant 280 mg
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
干预措施: telcagepant (Drug)
结局指标
主要结局
Percentage of Participants With Pain Freedom at Two Hours Post-dose
时间窗: 2 hours post-dose
Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).
Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)
时间窗: Up to 48 hours post-dose
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)
时间窗: Up to 14 days post-dose
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
次要结局
- Percentage of Participants With Pain Relief at 2 Hours Post-dose.(2 hours post-dose)