doorbraakpijn bij kanker BTcP pain in cancer
Conditions
Interventions
Patients will take either INFC or SLF at the start of an BTcP episode. Blood
samples and VAS scores will be taken before and 5, 10, 15, 20, 30, 45, 60, 90,
120 and 240 minutes after ROO administrati
fentanyl
pharmacokinetics
rapid onset
breakthrough cancer pain (BTcP)
Sponsors
Reinier de Graaf Groep
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Patients receiving stable maintenance opioid therapy for chronic cancer pain (as specified in SPCs of tested ROOs) * Patients suffering from BTcP, according to the Davies 2009 criteria. Both incidental and idiopathic BTcP. * Patients should have an average of 2 (and maximum of 4) episodes of BTcP per day * Patients must use one of the formulations used in this study for BTcP, either 100 or 200 µg Instanyl® or 200 or 400 µg Abstral®. * Patients must be mentally competent and therefore able to sign and date a written informed consent prior to entering the study
Exclusion criteria
Exclusion criteria: Sleep apnea, active brain metastases (with increased intracranial pressure), severe COPD, a recent history of substance abuse Allergy to one of the constituents of the ROOs Instanyl and Abstral Mucositis Participation in another clinical trial in the previous 4 weeks Use of MAO inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The determination of pharmacokinetic parameters of two transmucosal fentanyl products in patients with breakthrough cancer pain in a crossover design. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters are efficacy through pain intensity scores and patients* preference. | — |
Countries
The Netherlands
Outcome results
None listed