156
Participants
Start Date
December 31, 2007
Primary Completion Date
October 31, 2008
Study Completion Date
October 31, 2008
Fentanyl 1-day transdermal patch (Titration Phase)
Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14.
Fentanyl 1-day transdermal patch (Double Blind Phase)
Fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
Fentanyl 3-day transdermal patch (Double Blind Phase)
Fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
Placebo
Placebo matching to fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.
Placebo
Placebo matching to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.
Asahi
Asahikawa
Bunkyō City
Chiba
Chikushino-shi
Fukuoka
Fushimi
Higashi-Ibaraki
Himeji
Hirosaki
Hiroshima
Hitachi
Hohfu
Ichinomiya
Ikeda
Iwakuni
Kawachi-Nagano
Kawasaki
Kitakyushu
Kiyose
Kobe
Kochi
Matsue
Matsuyama
Nishinomiya
Okayama
Osaka
Ōita
Ōtake
Sakai
Sendai
Shigenobu N/A
Sonogishukugō
Sunto
Tamaho N/A
Tokushima
Tokyo
Toyohashi
Tsukuba
Utsunomiya
Wako
Yamaguchi
Yonago
Lead Sponsor
Janssen Pharmaceutical K.K.
INDUSTRY