To construct the utility surfaces of tapentadol and oxycodone.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) Changes in breath-to-breath minute ventilation as measured at
iso-hypercapnia; (2) Pain relief as measured by application of noxious stimuli
to the skin.
Secondary outcome
NA
Background summary
Opioids are potent pain killers and are used in soaring numbers to treat acute
and chronic pain. Opioids, however, come with several side effects that vary in
their severity and range from nausea/vomiting to life-threatening respiratory
depression. 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). These functions are based on the economy principle that all
actions have benefit and harm (UF = benefit * harm). We further developed these
functions in previous studies and now calculate a safety continuum or response
surface that allows assessment of P(benefit AND harm), and P(benefit AND NOT
harm), where P = probability. In this study we will determine the UF of two
commonly used opioids, tapentadol and oxycodone.
Study objective
To construct the utility surfaces of tapentadol and oxycodone.
Study design
An open-label 2 phase cross-over pharmacokinetic-pharmacodynamic modeling study
in healthy volunteers
Intervention
In phase 1, subjects will receive oral oxycodone (immediate release) on two
separate occasions, once for assessment of the respiratory effects and once for
assessment of the anti-nociceptive effects. In phase 2, subjects will receive
oral tapentadol (immediate release) on two separate occasions, once for
assessment of the respiratory effects and once for assessment of the
anti-nociceptive effects.
Study burden and risks
(1) The risks of the study are minor. Nausea is the main side effect expected
in this study that will be adequately treated with antiemetic medication.
Additionally, respiratory depression occurs under controlled conditions. (2)
The benefits of the study are considerable and related to the knowledge gained
with respect to the amount of respiratory depression that is obtained at
calibrated antinociception. The benefit relates to all individuals that at one
point will be treated with these potent painkillers.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers of either sex aged 18-38 years
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
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-003515-22-NL |
| CCMO | NL67486.058.18 |