Healthy volunteers R52.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Voluntary consent, healthy
Exclusion criteria
Exclusion criteria: Any acute and chronic illness/infection, use of medication in the last 7 days, alcohol and drug abuse, alcohol use 24 hours prior to participation, allergy to one of the substances used, participation in a clinical trial in the last 6 months, general anaesthesia in the last 6 months, knowledge of German in writing and language. For women: pregnancy, breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in the area under the pain curve (AUPC, =AUC, in %) during the cold pressor test from baseline to test (about 30 minutes after taking the study medication) as a measure of pain intensity in a group comparison. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is the change in pain tolerance (time to stop cold pressor test in seconds) as a surrogate marker of pain intensity from baseline to test in group comparison. Side effects and psychometric and vital parameters are collected exploratively. | — |
Countries
Germany
Contacts
Universitätsklinikum EssenKlinik für Neurologie