NCT00957983已完成1 期
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Headache
研究概览
简要总结
The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the headache expected during a Prostaglandin E2 infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
排除标准
- •Tension headache
- •All other primary forms of headache
- •Cardiovascular, Central Nervous system (CNS) and autoimmune diseases
- •Gastrointestinal disease
- •Previous or clinical signs of mental illness or substance abuse.
- •Participation in a clinical study of a medicinal product without regulatory approval or marketing authorisation within 1 month prior to this trial
- •Pregnancy/nursing
- •Daily intake of medication (except oral contraceptives)
研究组 & 干预措施
BGC20-1531 200mg
Active Comparator
干预措施: BGC20-1531 (Drug)
sugar pill
Placebo Comparator
干预措施: BGC20-1531 (Drug)
BGC20-1531 400mg
Active Comparator
干预措施: BGC20-1531 (Drug)
结局指标
主要结局
Headache
时间窗: 24 hours
次要结局
- rCBF, blood flow, diameter of STA/RA, HR, BP(in-hospital)
研究者
研究点 (1)
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