Healthy volunteers MedDRA version: 18.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852
Conditions
Interventions
Product Name: Diclometh
Pharmaceutical Form: Gel
INN or Proposed INN: 6-Dimethylamino-4,4-diphenyl-3-heptanone hydrochloride
CAS Number: 1095-90-5
Other descriptive name: METHADONE HYDROCHLORIDE
Conce
Sponsors
Aalborg University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Males from the ages of 18 years to 65 Intact skin in the area of drug application. Given informed consent to participate in this study. The participants must be able to read and understand Danish. Participants must be willing and be able to comply with the scheduled visits and trial procedures. Northern European descent (in order to minimize genetic variance influences on pain perception and drug metabolism). 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 21 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known hypersensitivity to methadone and/or diclofenac. Neurological or psychiatric disease sufficient , in the investigators opinion, to compromise the data collection. Participants with past or present history of substance abuse and/or patients using any illegal substances. Use of prescription medicine and/or herbal medicine Participants takingUse of over-the-counter medication 24 hours before and in each study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To compare 2 doses of diclometh (diclofenac and methadone formulation) versus placebo by assessing effects by experimental pain models. ;Secondary Objective: 2) To assess the safety profile of diclometh and to determine diclometh absorption into systemic circulation. ;Primary end point(s): Difference in capsaicin induced allodynia and hyperalgesia between placebo and active treatments. ;Timepoint(s) of evaluation of this end point: Difference in capsaicin induced allodynia and hyperalgesia between placebo and active treatments measured by experimental pain models such as muscle pain stimulation, skin heat stimulation, brush and von Frey filament (on day 1 in each study period). Assessments will be performed at baseline, 0, 30, 60, 90 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in Nerve Growth factor (NGF) induced allodynia and hyperalgesia between placebo and active treatments. Side effects profile during treatment period. Methadone and diclofenac absorption into systemic circulation. ;Timepoint(s) of evaluation of this end point: Difference in Nerve Growth factor (NGF) induced allodynia and hyperalgesia between placebo and active treatments measured each day in all three study periods using experimental pain models such as muscle pain stimulation, skin heat stimulation, brush and von Frey filament. Assessments will be performed at baseline, 0, 30, 60, 90 minutes and 24 hours. Side effects profile during treatment period (registration of side effects during each study period and at follow up phone call Methadone and diclofenac absorption into systemic circulation (will be assessed by pharmacokinetic sampling). | — |
Countries
Denmark
Contacts
Public ContactMech-Sense
Mech-Sense, Aalborg University Hospital
Outcome results
None listed