A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
PainCancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (43)

Unknown

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

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT00644787 - A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain | Biotech Hunter | Biotech Hunter