A clinical study investigating the analgesic effects of Midazolam compared to an inactive substance (placebo) in human volunteer subjects with the use of Fentanyl as an active (i.e. analgesic) control substance whereby all participants receive all treatments.

Phase 1

• Conditions: nociceptive pain; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2015-004097-15-AT
• Lead Sponsor: Wilhelminenspital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-21
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•male or female
•18-40 years old
•healthy
•body mass index between 5th and 85th percentile
•Caucasian
•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

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
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified