Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients
This study is open-label, single-arm, multicenter, prospective study to evaluate the
usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient
satisfaction when administrating fentanyl matrix (a background pain treatment, and a
breakthrough pain treatment) for patients with lung cancer for 21 days. Fentanyl
transdermal patch-type system is designed to deliver medication at a nearly constant amount
per unit time into the body through the skin for 3 days (72 hours). Studies about
transdermal fentanyl have found that it had analgesic effects on malignant pain, and most
patients receiving the medication preferred fentanyl because they experienced less
constipation. Safety assessments will include adverse event monitoring, vital signs,
laboratory work. starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the
investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient's satisfaction with pain treatment as measured by 5-point verbal scale
Day 1, 8 and 22
No
Janssen Korea, Ltd. Clinical Trial
Study Director
Janssen Korea, Ltd.
Korea: Food and Drug Administration
CR012259
NCT01060137
May 2006
May 2007
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