Chronic pain
Conditions
Interventions
Trade Name: Pallexia
Product Name: Tapentadol
Product Code: N02AX06
Pharmaceutical Form: Tablet
Trade Name: Oxycodone
P
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male and female volunteers 18-38 years 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 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Presence of health issues including presence or history of any psychiatric, medical or neurologic disorder that may interfere with the current study (eg. neuropathic pain conditions); - Presence or a history of illicit drug use or excessive alcohol consumption (>21 units per week), - Known allergies to study medication. - A positive drug screen on the day of screening or on any of the study days, - Participation in another trial in the 3 months before enrolment, - Use of medication on a regular basis (e.g. pain medication), - Inability to fast for at least 8 hours prior to study treatment administration, - Pregnancy or lactation, - Inability to communicate with the research team - surgery during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To creatie utility functions for tapentadol and oxycodone;Secondary Objective: None;Primary end point(s): The utility of the drug in terms of benefit vs harm where benefit is analgesia and harm respiratory depression;Timepoint(s) of evaluation of this end point: followlnmg intake for the 6 hours of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Netherlands
Contacts
Public ContactAlbert Dahan
LUMC
Outcome results
None listed