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ID
Source
Brief title
Health condition
Healthy volunteers
Characteristics of oxycodone and tapentadol.
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Changes in breath-to-breath minute ventilation as measured at iso-hypercapnia;
- Change in nociception using experimental pain models
Secondary outcome
The drug concentration, respiratory and pain end-points will be used for construction of the Utility Functions.
Background summary
Opioids differ in the characteristics with respect to wanted effect (analgesia) and side effects (eg. respiratory depression). These effects are best viewed concomitantly allowing comparison between opioid. One way of describing these effects simultaneously is by construction of safety or utility function (UF). In this study, we will determine the UF of two commonly used opioids, tapentadol and oxycodone.
Study objective
In the current study, we will construct utility functions of two opioids, tapentadol and oxycodone, to assess the benefit/harm ratio of these drugs. To that end we will perform a PK PD study in healthy volunteers
Study design
Each subject will be treated 4 times, with at least 1 week in between visits. Each visit will last approximately 8 hours with.
Intervention
Subjects will receive oral tapentadol on two separate occasions, once for assessment of the respiratory effects and once for assessment of the anti-nociceptive effects. Subjects will receive oral oxycodone on the other two separate occasions, once for assessment of the respiratory effects and once for assessment of the anti-nociceptive effects.
Albinusdreef 2
M. Velzen, van
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
m.van_velzen@lumc.nl
Albinusdreef 2
M. Velzen, van
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
m.van_velzen@lumc.nl
Inclusion criteria
- Healthy according to medical history, physical examination, vital signs, lab values, and ECG;
- Age 18-38 years;
- Able to give informed consent;
- Body mass index < 30 kg/m2.
- Female subjects on contraceptives.
Exclusion criteria
- 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
- Elective surgery during the study period.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7454 |
| NTR-old | NTR7696 |
| Other | METC Leiden Den Haag Delft : P18.212 LUMC |