Healthy volunteers - pain MedDRA version: 16.1 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 100000004867
Conditions
Interventions
Trade Name: Oxycontin
Product Name: oxycodon
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: oxycodone
CAS Number: 124-90-3
Current Sponsor code: oxycodone
Other descriptive n
Sponsors
Mech-Sense, Aalborg University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Signed informed consent before any study specific procedures • Able to read and understand Danish. • The researcher believes that the participant understands what the study entails, are capable of following instructions, are able to attend when needed, are expected to complete the study • Male • Between 20 and 35 years of age • Healthy 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Female • Known allergy towards pharmaceutical compounds similar to those used in the study • Participation in other studies within 14 days of first visit • Expected need of medical/surgical treatment during the course of the study • History of psychiatric illness • History of persistent or recurring pain conditions • History of substance abuse • Family history of substance abuse • Use of any analgesic medication within 24 hours before start as well as for the duration of the study period • Use of prescription medicine and/or herbal medicine • Need to drive motor vehicle within the treatment periods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to establish a model that is capable of evaluating the effects of analgesics on the pain matrix on both peripheral, spinal, supraspinal, and modulatory level. ;Secondary Objective: Secondary objectives include assessing the sensitivity of such a model to a Serotonin–norepinephrine reuptake inhibitor drug. ;Primary end point(s): To evaluate changes in pain sensitivity (as measured from the nociceptive withdrawal reflex, spinal evoked potentials, electroencephalographic spectral analysis) towards electrical stimulation between placebo and active medications;Timepoint(s) of evaluation of this end point: At baseline and after 5 days/8 doses | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate changes in subjective pain experience (as measured by numerical rating scales) towards electrical stimulation between placebo and active medications;Timepoint(s) of evaluation of this end point: At baseline and after 5 days/8 doses | — |
Countries
Denmark
Contacts
Public ContactDepartment of Gastroenterology
Mech-Sense, Aalborg University Hospital
Outcome results
None listed