NCT01327118已完成不适用
Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin F2alpha
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Headache score on a 10-point verbal rating scale (VRS) 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache
研究概览
简要总结
The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Primary Headache
- •Headache on the day of the investigation
- •Hypertension
- •Hypotension
- •Pregnant/nursing
- •Daily intake of medication (except oral contraceptives)
- •Cardiovascular or central nervous system (CNS) disease
- •Drug/alcohol abuse
- •Psychiatric disease
研究组 & 干预措施
Isoton sodium chloride
Placebo Comparator
干预措施: Isoton sodium chloride (Drug)
Prostaglandin F2alpha
Active Comparator
干预措施: Prostaglandin F2alpha (Drug)
结局指标
主要结局
Headache score on a 10-point verbal rating scale (VRS) 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache
时间窗: 24 h.
incidence of headache
次要结局
- diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan(in-hospital 2 h.)
- Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz)(in-hospital 2 h.)
- mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore®(in-hospital 2 h.)
- electrocardiography (ECG)(in-hospital 2 h.)
研究者
研究点 (1)
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