Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)
2015年6月8日 更新者：Merck Sharp & Dohme LLC
A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK0974 in the Acute Treatment of Migraine With or Without Aura
The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.
研究概览
研究类型
介入性
注册 (实际的)
1703
阶段
- 第三阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patient has at least 1 year history of migraine (with or without aura)
- Females of childbearing years must use acceptable contraception throughout trial
Exclusion Criteria:
- Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
- Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
- Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
- Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
- Patient has a history of cancer within the last 5 years
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：MK0974 50 mg
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
|
其他名称：
|
|
实验性的：MK0974 150 mg
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
|
其他名称：
|
|
实验性的：MK0974 300 mg
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
|
其他名称：
|
|
安慰剂比较：Placebo
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
|
MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Patients Reporting Pain Freedom at 2 Hours Postdose
大体时间：2 hours post dose
|
Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain. |
2 hours post dose
|
|
Number of Patients Reporting Pain Relief at 2 Hours Post Dose
大体时间：2 hours post dose
|
Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain. |
2 hours post dose
|
|
Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose
大体时间：2 hours post dose
|
Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.
|
2 hours post dose
|
|
Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose
大体时间：2 hours post dose
|
Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.
|
2 hours post dose
|
|
Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose
大体时间：2 hours post dose
|
Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.
|
2 hours post dose
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose
大体时间：2 to 24 hours postdose
|
Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.
|
2 to 24 hours postdose
|
|
Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose
大体时间：2 to 24 hours postdose
|
Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.
|
2 to 24 hours postdose
|
|
Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose
大体时间：2 hours postdose
|
Pain Freedom and no migraine-associated symptoms at 2 hours postdose.
|
2 hours postdose
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年3月1日
初级完成 (实际的)
2007年12月1日
研究完成 (实际的)
2007年12月1日
研究注册日期
首次提交
2007年2月5日
首先提交符合 QC 标准的
2007年2月5日
首次发布 (估计)
2007年2月7日
研究记录更新
最后更新发布 (估计)
2015年7月3日
上次提交的符合 QC 标准的更新
2015年6月8日
最后验证
2015年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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