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Effects of anatomical localization of the fentanyl patch on the pharmacokinetics and pharmacodynamics of fentanyl: A randomised cross-over trial.


- candidate number13420
- NTR NumberNTR3654
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-okt-2012
- Secondary IDs2012-193 / 2012-000999-41; METC / EudraCTnumber
- Public TitleEffects of anatomical localization of the fentanyl patch on the pharmacokinetics and pharmacodynamics of fentanyl: A randomised cross-over trial.
- Scientific TitleEffects of anatomical localization of the fentanyl patch on the pharmacokinetics and pharmacodynamics of fentanyl: A randomised cross-over trial.
- ACRONYM
- hypothesisFentanyl is highly lipophilic. Localizations with a thicker fatlayer absorp more fentanyl than localizations with a thinner fatlayer. When patients stick the patch in different localizations this can lead to different concentrations of fentanyl. With consequences of underdosing or overdosing the fentanyl.
- Healt Condition(s) or Problem(s) studiedFentanyl patch, Cancer patients
- Inclusion criteria1. Stable use of fentanyl patch;
2. 18 years or older;
3. Written informed consent;
4. Stable comedication.
- Exclusion criteria1. Fentanyl rescue medication;
2. Mentally disabled or suffering from a psychiatric disease.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-okt-2012
- planned closingdate1-okt-2013
- Target number of participants14
- InterventionsPatients will be asked to stick the fentanyl patch to the upper arm during 9 (3x3) days. Then pharmacokinetic samples will be taken. Afterwards they stick the patch to the ventral thorax and pharmacokinetic samples will be taken. Or vice versa.
- Primary outcomeAUC and clearance.
- Secondary outcomeDifference in pain scale.
- Timepoints1 year.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. E.J.M. Kuip
- CONTACT for SCIENTIFIC QUERIESDrs. E.J.M. Kuip
- Sponsor/Initiator Erasmus Medical Center, Daniel den Hoed Cancer Center
- Funding
(Source(s) of Monetary or Material Support)
Nuts/Ohra
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD8-okt-2012 - 22-okt-2012


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