No registrations found.
ID
Source
Health condition
All patients using a stable dose of a fentanyl (Durogesic ®) patch (for at least 8 days).
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints. Pharmacokinetics (clearance, AUC etc)
Secondary outcome
not applicable
Background summary
SUMMARY
Rationale: Fentanyl is a strong opioïd and is highly lipophilic. Fentanyl pharmacokinetics are characterised by large inter- and inpatient differences, which may have serious consequences for the activity and toxicity profile of this drug. In this study we explore the influence of BMI and smoking behaviour on the pharmacokinetics (i.e. clearance (CL)) of fentanyl.
Objective: Primary objective: To study the relation between BMI and the pharmacokinetics of fentanyl, in patients using a stable dose of the fentanyl patch (Durogesic ®). Secundary objective: to study the relation between smoking and the pharmacokinetics of fentanyl, in patients using a stable dose of the fentanyl patch (Durogesic ®).
Study design: explorative cohort study
Study population: All patients using a stable dose of a fentanyl (Durogesic ®) patch (for at least 8 days).
Intervention (if applicable): not applicable
Main study parameters/endpoints: Pharmacokinetics (Clearance, AUC, etc.)
Study objective
Fentanyl is a strong opioïd and is highly lipophilic. Fentanyl pharmacokinetics are characterised by large inter- and inpatient differences, which may have serious consequences for the activity and toxicity profile of this drug. In this study we explore the influence of BMI and smoking behaviour on the pharmacokinetics (i.e. clearance (CL)) of fentanyl.
Study design
not applicable
Intervention
not applicable
W.H. Oldenmenger
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391439
w.h.oldenmenger@erasmusmc.nl
W.H. Oldenmenger
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391439
w.h.oldenmenger@erasmusmc.nl
Inclusion criteria
• age > 18 years;
• stable use and dose of fentanyl patch (Durogesic ®) for at least 8 days, 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.
Design
Recruitment
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 | NL4496 |
| NTR-old | NTR4672 |
| Other | Erasmus MC : MEC-2013-412 |