This is a volunteer study in healthy volunteers. Pain research, reversal of hyperalgesia by IMP is studied.
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Men or women, aged between 19 and 40 years Body mass index between 15th and 85th percentile Normal findings in the medical history and physical examination drug free for 1 week prior to the study day 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy Any disease Ongoing pain Older than 40 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Area of pin prick hyperalgesia 6 hours after stop of IMP;Main Objective: To study the reversal of established hyperalgesia. The main outcome variable will be: area of pin prick hyperalgesia.;Secondary Objective: To study the reversal effect on additional outcome variables for mechanical hyperalgesia will be: Stimulus response (SR)-function to a set of modified rigid von Frey filaments (8-512mN), area of dynamic allodynia to brush and SR-function to dynamic mechanical stimuli. Pain immediately after injection and heat pain threshold within the area of mechanical hyperalgesia will serve as additional outcome variables. | — |
Countries
Austria