This is a volunteer study in healthy volunteers. Pain research, reversal of hyperalgesia by IMP is studied
Conditions
Sponsors
Abteilung für Anaesthesie und Intensivmedizin, Medizinische Universität Wien
Eligibility
Sex/Gender
All
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: Any of the following will exclude a subject from the study: • Regular use of medication especially analgesics • Abuse of alcoholic beverages, drug abuse • History of asthma • Participation in a clinical trial in the 2 weeks preceding the study • Symptoms of a clinically relevant illness in the 2 weeks before the first study day • Resting systolic blood pressure >135 mmHg or diastolic blood pressure >85 mmHg • Acute skin diseases like sunburn or skin lesions on the relevant areas and UV sensitive skin conditions, like Xeroderma pigmentosa • Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, area of dynamic allodynia to brush. Heat pain threshold within the area of mechanical hyperalgesia will serve as additional outcome variable.;Primary end point(s): Area of pinprick hyperalgesia 6 hours after discontinuation of IMP | — |
Countries
Austria
Outcome results
None listed