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
ID
Bron
Verkorte titel
Aandoening
Healthy volunteers
Characteristics of oxycodone and tapentadol.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Changes in breath-to-breath minute ventilation as measured at iso-hypercapnia; <br>
- Change in nociception using experimental pain models
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Each subject will be treated 4 times, with at least 1 week in between visits. Each visit will last approximately 8 hours with.
Onderzoeksproduct en/of interventie
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.
Publiek
Albinusdreef 2
M. Velzen, van
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
m.van_velzen@lumc.nl
Wetenschappelijk
Albinusdreef 2
M. Velzen, van
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
m.van_velzen@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7454 |
| NTR-old | NTR7696 |
| Ander register | METC Leiden Den Haag Delft : P18.212 LUMC |