High-dose Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study
This is a multi-center, open-label (all people know the identity of the intervention),
prospective (the patients are identified and then followed forward in time for the outcome
of the study) observational study. The study population comprises patients who are admitted
to a study center during the study period and are receiving a strong oral long-acting opioid
analgesic but deemed to control pain insufficiently. Since this study is an observational
study conducted in real practice, a dose of fentanyl matrix should be adjusted depending on
an individual patient's response at the investigator's discretion. However, for the patients
whose pain is not sufficiently controlled despite administration of strong long-acting
opioid analgesics, the minimum initial dose will be fentanyl matrix 75 micrograms/h and the
investigator can adjust dosage according to the degree of the patients' pain control during
the 9 days of the study period.
Observational
Observational Model: Cohort, Time Perspective: Prospective
The percentage of patients who are very satisfied or satisfied with the pain treatment after the study drug administration
The overall satisfaction is measured by a 5-point scale. Patients' answers are rated as: "very satisfied", "satisfied", "fair", "dissatisfied", or "very dissatisfied".
Day 10
No
Janssen Korea, Ltd., Korea Clinical Trial
Study Director
Janssen Korea, Ltd., Korea
Korea: Food and Drug Administration
CR015778
NCT01816503
December 2008
July 2009
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