|- candidate number||15759|
|- NTR Number||NTR4288|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-nov-2013|
|- Secondary IDs||MECT number MEC-2013-412|
|- Public Title||Does Aprepitant (Emend «) influence fentanyl PK?|
|- Scientific Title||Effects of aprepitant (Emend «) on the pharmacokinetics of fentanyl (Durogesic «)|
|- hypothesis||Fentanyl is a strong opio´d and is highly lipophilic. Fentanyl pharmacokinetics are characterised by large inter- and intrapatient differences, which may have serious consequences for the activity and toxicity profile of this drug. The use of concurrent medication interacting with fentanyl metabolism may importantly contribute to this heterogeneity. In this study we study the influence of aprepitant (Emend «) on the pharmacokinetics (i.e. clearance (CL)) of fentanyl.|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||- age >= 18 years;|
- stable use and dose of fentanyl patch (Durogesic «) for at least 2 weeks irrespective of the dose used;
- written informed consent.
|- Exclusion criteria||- Using fentanyl as rescue medication (other opioids are allowed)|
- serious psychiatric illness, confusion of intellectual disability
- The use of strong cytochrome P450 inhibitors or inducers (as identified in the Flockhart table; appendix C).
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2013|
|- planned closingdate||1-dec-2015|
|- Target number of participants||14|
|- Interventions||- taking 3 days of aprepitant|
- 2x pharmacokinetic sampling
|- Primary outcome||Fentanyl pharmacokinetics (i.e.clearance).|
|- Secondary outcome||- side effects according the CTC toxicity criteria|
- differences in pain intensity according the NRS
|- Timepoints||- pharmacokinetic sampling is done in 2 periods, one with and one without aprepitant|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MSc. W.H. Oldenmenger|
|- CONTACT for SCIENTIFIC QUERIES||MSc. W.H. Oldenmenger|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Nuts/Ohra|
|- Brief summary||SUMMARY
Rationale: Fentanyl is a strong opio´d and is highly lipophilic. Fentanyl pharmacokinetics are characterised by large inter- and intrapatient differences, which may have serious consequences for the activity and toxicity profile of this drug. The use of concurrent medication interacting with fentanyl metabolism may importantly contribute to this heterogeneity. In this study we study the influence of aprepitant (Emend «) on the pharmacokinetics (i.e. clearance (CL)) of fentanyl.
Objective: To study the influence of aprepitant (Emend «) on the pharmacokinetics of fentanyl, in patients using a stable dose of the fentanyl patch (Durogesic «).
Study design: intervention study
Study population: All patients using a stable dose of a fentanyl (Durogesic «) patch (for at least 8 days, to guarantee steady state).
Intervention: administration of aprepitant (Emend «) following the Erasmus MC regular treatment regimen to prevent severe chemotherapy-induced nausea.
Main study parameters/endpoints: Pharmacokinetics of fentanyl (Clearance, AUC, etc.)
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study has a low risk for the participating patients. At two separate days three blood samples are taken (once after the administration of aprepitant, and once without aprepitant co-treatment). Aprepitant is regularly used as an anti-emetic in case of highly emetogenic chemotherapy. It has little side effects (see paragraph 6.4). Although, there is no direct benefit for the patient to participate into this study, results will be helpful to safely dose fentanyl in combination with CYP3A4 inhibiting medication in the future.
|- Main changes (audit trail)|
|- RECORD||27-nov-2013 - 11-dec-2016|