Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids
This is an open-label (all people know the identity of the intervention), single-arm,
multicenter (conducted in more than one hospital or medical school team work on a medical
research study), prospective (study following participants forward in time) study conducted
to assess the efficacy and safety of TTS-fentanyl D-trans in cancer participants of Korea
with inadequately controlled pain by non-narcotic analgesics and for participant's
satisfaction. The participants will receive the initial dose of TTS-fentanyl D-trans patch
releasing 12 micrograms per hour (12 mcg/hr) of fentanyl and will be increased by 12 mcg/hr
or 25 mcg/hr, every 3 days depending on the participant's pain control. Efficacy will
primarily be evaluated by participant's satisfaction with pain treatment. Participant's
safety will be monitored throughout the study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Satisfied With Pain Treatment
Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.
Day 29
No
Janssen Korea, Ltd., Korea Clinical Trial
Study Director
Janssen Korea, Ltd., Korea
Korea: Food and Drug Administration
CR012256
NCT01060124
April 2007
February 2009
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