Effect of the location where you stick the fentanyl patch on its drug levels.

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000999-41-NL

Enrollment

Registered

2012-04-17

Start date

2012-09-28

Completion date

Unknown

Last updated

2012-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer patients using a stable dose of a fentanyl patch as treatment for their continuous pain MedDRA version: 14.1 Level: PT Classification code 10058019 Term: Cancer pain System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: durogesic Product Name: durogesic Product Code: PA 748/2/1-5 Pharmaceutical Form: Transdermal patch INN or Proposed INN: FENTANYL CAS Number: 437-38-7 Concentration unit: µg microgram(s) C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • age = 18 years • stable use of fentanyl patch • written informed consent • stable co-medication • no serious psychiatric illness of intellectual disability Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - using fentanyl as rescue medication

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the influence of the localization of the fentanyl patch on the pharmacokinetics of fentanyl.;Secondary Objective: To investigate if difference in localization of the fentanyl patch makes a difference in pain scores.;Primary end point(s): Determine differences in fentanyl pharmacokinetics when the fentanyl patch is used in different anatomical localizations.;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Main Objective: To determine the influence of the localization of the fentanyl patch on the pharmacokinetics of fentanyl.;Secondary Objective: To investigate if difference in localization of the fentanyl patch makes a difference in pain scores.;Primary end point(s): Determine differences in fentanyl pharmacokinetics when the fentanyl patch is used in different anatomical localizations.;Timepoint(s) of evaluation of this end point: 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): Determine differences in painscores depending of the anatomical localization of the fentanyl patch.;Timepoint(s) of evaluation of this end point: 1 year	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026