Study of Local Physiological Effects Following Intradermal and Intramuscular Injection of Levcromacalim
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Occurrence and change of Itching from baseline
研究概览
简要总结
Intradermal and intramuscular injection of levcromacalim and placebo (sterile saline) on the forehead and forearm of healthy subjects and the following will be investigated:
- Prevalence and intensity of pain
- Prevalence and intensity of itching
- Occurrence and intensity of local redness and swelling
- Occurrence and intensity of local changes in skin temperature and blood flow
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of both sexes.
- •18-60 years.
- •Women of childbearing potential must use adequate contraception.
排除标准
- •A history of serious somatic disease
- •Migraine or any other type of headache (except episodic tension-type headache less than once a month)
- •Daily intake of any medication except contraceptives
研究组 & 干预措施
Saline
To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
To give 0,05 ml intradermal and 0.2 intramuscular of saline after baseline time 0.
干预措施: Saline (Drug)
Levcromakalim
To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
To give 0,05 ml intradermal and 0.2 intramuscular of 150 ug/ml levcromakalim after baseline time 0.
干预措施: Levcromakalim (Drug)
Levcromakalim
To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
To give 0,05 ml intradermal and 0.2 intramuscular of 150 ug/ml levcromakalim after baseline time 0.
干预措施: Saline (Drug)
Saline
To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
To give 0,05 ml intradermal and 0.2 intramuscular of saline after baseline time 0.
干预措施: Levcromakalim (Drug)
结局指标
主要结局
Occurrence and change of Itching from baseline
时间窗: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection
Occurrence and intensity of Itching after levcromakalim injektion compared to placebo. To measure itching numerical rating scale (NRS) 0-10 will be used. The outcome measure is itching and the unit that will be used to measure the itching is NRS.
Occurrence and change of pain from baseline
时间窗: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection
Occurrence and intensity of pain after levcromakalim injektion compared to placebo. To measure pain numerical rating scale (NRS) 0-10 will be used. The outcome measure is pain and the unit that will be used to measure the pain is NRS.
次要结局
- Occurrence and change of swelling from baseline(Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.)
- Occurrence and change of redness from baseline(Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.)
- Change of blood flow from baseline(Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.)
- Change of skin temperature from baseline(Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.)
研究者
Mohammad Al-Mahdi Al-Karagholi
MD, PhD student, Principal investigator
Danish Headache Center