EUCTR2015-004097-15-AT进行中（未招募）1 期
A single center, prospective, randomized, double blind, placebo-controlled, three-way cross-over study of the analgesic effects of Midazolam versus Placebo with Fentanyl as an active control in human volunteers. - Analgesic effects of Midazolam in human volunteers
Wilhelminenspital0 个研究点开始时间: 2015年9月21日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •male or female
- •18-40 years old
- •body mass index between 5th and 85th percentile
- •non smoker or moderate smoker (<10 cigarettes per day)
- •able to understand, write, and read German
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •acute or chronic pain condition (except for mild day-to-day pain on <5 days/month)
- •previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics
- •symptoms of a clinically relevant illness in the 2 weeks before the first study day
- •hypertension
- •any known psychiatric condition
- •abuse of alcoholic beverages, drug abuse
- •known positive human immunodeficiency virus status
- •any known medical condition which may interact with study medication, study objectives, or compliance of subject with study tasks
- •participation in a clinical trial in the 4 weeks preceding the study
- •known allergy against Midazolam
- •known allergy against Fentanyl
- •pregnancy or breast-feeding
- •unable or unwilling to give informed consent
- •unable or unwilling to follow investigator’s instructions
- •unable or unwilling to comply with study protocol
研究者
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