Healthy volunteers - pain MedDRA version: 20.1 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 100000004867
Conditions
Interventions
Trade Name: Palexia Depot
Product Name: Palexia Depot
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Tapentadol
CAS Number: 175591-23-8
Other descriptive name: TAPENTADOL
Concentrat
Sponsors
Asbjørn Mohr Drewes
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 45 years of age • Scandinavian descent • Healthy • Opioid naïve subjects (who have not taken opioid doses for 1 week or longer) 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: • • 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 • Nicotine consumption • Daily alcohol consumption • History of substance abuse • Family history of substance abuse • Use of any analgesic medication within 48 hours before start as well as for the duration of the study period • Use of any medication (herbal as well as any over-the-counter drugs) within 48 hours before start of the study period • Intake of alcohol within 24 hours before start of the study period • Use of prescription medicine and/or herbal medicine • Need to drive motor vehicle within the treatment periods • Severe respiratory depression • Increased intracranial pressure • Paralytic ileus • Severe decreased renal or hepatic function • Treatment with MAO-inhibitors • Cor pulmonale • Severe COPD or acute severe asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objectives are to investigate the effect of tapentadol on the central, the autonomic and the enteric nervous systems.;Secondary Objective: Secondary objectives are to show that tapentadol has less effect on the autonomic and enteric nervous system in comparison with oxycodone.;Primary end point(s): The primary end points will be to evaluate potential changes in pain sensitivity (as measured from the withdrawal reflex, spinal EPs, etc.) towards electrical, mechanical and thermal stimulation and to assess the effect on the autonomic (measured from brainstem parasympathetic efferent activity, known as cardiac vagal tone) and enteric (measured by assassing the gut transit time and MR colonography) nervous systems. ;Timepoint(s) of evaluation of this end point: At baseline and after 14 days of treatment. Gut transit is evaluated after 4 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate changes in subjective pain experience (as measured by numerical rating scales) towards nociceptive stimulation between placebo and active medications. To evaluate changes in subjective experience of the effect on the enteric nervous system (measured by questionnaires) between placebo and active medications. ;Timepoint(s) of evaluation of this end point: At baseline and after 14 days of treatment. | — |
Countries
Denmark
Contacts
Public ContactRasmus Bach Nedergaard
Mech-Sense, Aalborg University Hospital
Outcome results
None listed