E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cancer patients using a stable dose of a fentanyl patch as treatment for their continuous pain |
kankerpatienten die een stabiele dosering van de fentanylpleister gebruiken ivm continue pijn |
|
E.1.1.1 | Medical condition in easily understood language |
cancer patients with pain |
kankerpatienten met pijn |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10058019 |
E.1.2 | Term | Cancer pain |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the influence of the localization of the fentanyl patch on the pharmacokinetics of fentanyl. |
Bepalen van de invloed van de plaats van de fentanylpleister op de farmacokinetiek van fentanyl. |
|
E.2.2 | Secondary objectives of the trial |
To investigate if difference in localization of the fentanyl patch makes a difference in pain scores. |
Onderzoeken of verschil in de plaats van de fentanylpleister een verschil maakt in de pijnscore. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• age ≥ 18 years
• stable use of fentanyl patch
• written informed consent
• stable co-medication
• no serious psychiatric illness of intellectual disability
|
• 18 jaar of ouder
• stabiel gebruik van fentanylpleister
• getekend informed consent
• stabiele co-medicatie
• geen ernstige psychiatrische ziekte of mentale retardatie |
|
E.4 | Principal exclusion criteria |
- using fentanyl as rescue medication |
- het gebruik van fentanyl als rescue medicatie |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Determine differences in fentanyl pharmacokinetics when the fentanyl patch is used in different anatomical localizations. |
Bepalen van verschillen in fentanyl farmacokinetiek bij het plakken van de fentanylpleister op verschillende plekken. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Determine differences in painscores depending of the anatomical localization of the fentanyl patch. |
Bepalen van verschillen in pijnscores afhankelijk van de anatomische lokatie van de fentanyl pleister. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
10 patients will be included and analysis will be performed on 10 patients. |
10 patienten zullen geincludeerd en geanalyseerd worden. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |