Research with human participants

Overview of medical research in the Netherlands

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

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON23508

Source

Nationaal Trial Register

Health condition

- cancer patients
- fentanyl patch
- kankerpatienten
- fentanylpleister

Sponsors and support

Primary sponsor :
Erasmus Medical Center, Daniel den Hoed Cancer Center
Source(s) of monetary or material Support :
NUTS/OHRA

Intervention

Outcome measures

Primary outcome

AUC and clearance.

Secondary outcome

Difference in pain scale.

Background summary

N/A

Study objective

Fentanyl 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.

Study design

1 year.

Intervention

Patients 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.

Public
Erasmus Medical Center, Daniel den Hoed Cancer Center, P.O. Box 5201
W.H. Oldenmenger
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391439
w.h.oldenmenger@erasmusmc.nl
Scientific
Erasmus Medical Center, Daniel den Hoed Cancer Center, P.O. Box 5201
W.H. Oldenmenger
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391439
w.h.oldenmenger@erasmusmc.nl

Inclusion criteria

1. Stable use of fentanyl patch;

2. 18 years or older;

3. Written informed consent;

4. Stable comedication.

Exclusion criteria

1. Fentanyl rescue medication;

2. Mentally disabled or suffering from a psychiatric disease.

Design

Study type :
Interventional
Intervention model
:
Crossover
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
14
Type :
Actual

Positive opinion
Date :
Application type :
First submission

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
NTR-new NL3507
NTR-old NTR3654
Other METC / EudraCTnumber : 2012-193 / 2012-000999-41;
ISRCTN ISRCTN wordt niet meer aangevraagd.

Summary results

N/A