Rotation from subcutaneous infusion to transdermal administration of fentanyl: A validation ofcurrent practice
- Conditions
- Cancer-related pain
- Registration Number
- NL-OMON26606
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Age > 18 years
Able to understand the written information and able to give informed consent.
Current treatment with subcutaneous fentanyl and planned to rotate to transdermal
fentanyl
To ensure steady-state kinetics, patients must have been treated with
subcutaneous fentanyl for at least 40 hours prior to the rotation and have been
treated with a stable fentanyl dose at least 20 hours prior to the rotation This way,
fentanyl pharmacokinetics are at steady-state.
Patients that use short-acting fentanyl via the oral, (oral mucosal, sublingual),
intranasal or subcutaneous administration route 12 hours prior to the rotation will
be excluded as this influences the pharmacokinetic profile of the subcutaneous
administration. This implicates that patients will be prescribed oral short acting
oxycodone or morphine 12 hours before rotation as these are mostly used next to
treatment with transdermal fentanyl.
Patients that use strong CYP3A4 inhibitors or inducers will be excluded as the
model did not account for the influence of strong CYP3A4 inhibition or induction on
fentanyl pharmacokinetics while the effects have been shown in multiple studies
Patients that are rotated using a dose conversion ratio other than 1:1 will also be
excluded.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To prove bioequivalence in fentanyl exposure (measured as area under the curve (AUC)) pre- and post-rotation.
- Secondary Outcome Measures
Name Time Method To associate the occurrence and severity of adverse events and pain scores pre- and post-rotation with pharmacokinetic parameters.