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Effects of body mass index (BMI) and smoking on the pharmacokinetics of fentanyl


- candidate number18300
- NTR NumberNTR4672
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jul-2014
- Secondary IDsMEC-2013-412 Erasmus MC
- Public TitleEffects of body mass index (BMI) and smoking on the pharmacokinetics of fentanyl
- Scientific TitleEffects of body mass index (BMI) and smoking on the pharmacokinetics of fentanyl
- ACRONYM
- hypothesisFentanyl 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.
- Healt Condition(s) or Problem(s) studiedFentanyl
- 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate31-dec-2015
- Target number of participants80
- Interventionsnot applicable
- Primary outcomeMain study parameters/endpoints. Pharmacokinetics (clearance, AUC etc)
- Secondary outcomenot applicable
- Timepointsnot applicable
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc. W.H. Oldenmenger
- CONTACT for SCIENTIFIC QUERIESMSc. W.H. Oldenmenger
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Nuts/Ohra
- Publications
- Brief summarySUMMARY

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.)
- Main changes (audit trail)
- RECORD7-jul-2014 - 11-dec-2016


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