EUCTR2006-004257-14-NL进行中(未招募)1 期
A Multicenter, Double-Blind, Placebo and Active-Controlled, Parallel Group Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo and Zolmitriptan for the Acute Treatment of Migraine With or Without Aura - MK-0974 Pivotal Study 1 - worldwide (with active comparator)
Merck Sharp & Dohme (MSD)0 个研究点目标入组 1,800 人开始时间: 2006年11月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 1,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patient has at least 1 year history of migraine (with or without aura).
- •Females of child bearing potential must use acceptable contraception throughout trial.
- •Patient is in general good health based on screening assessment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient is pregnant/breast-feeding (or is a female expecting to conceive during study period).
- •Patient has uncontrolled hypertension (high blood pressure), uncontrolled diabetes, HIV disease, or other significant 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.
- •Patient has history or presence of a significant cardiovascular disorder (e.g. acute
- •coronary syndrome [e.g. MI or unstable angina]; coronary artery intervention [e.g.
- •CABG or PTCA]; congestive heart failure or arrhythmia.
- •Note: Patients with evidence of an MI on ECG will be excluded.
研究者
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