EUCTR2015-004097-15-AT
Active, not recruiting
Phase 1
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 sitesSeptember 21, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- nociceptive pain
- Sponsor
- Wilhelminenspital
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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