Clinical trial NCT00644787
Conditions: Pain Cancer
Keywords: Pain Cancer Fentanyl JNS020QD JNS005
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2007-12-01; Completion date: 2008-10-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl 1-day application transdermal patch to fentanyl 3-day application (JNS005) transdermal patch in participants with cancer pain.

Detailed description:
This is a multi-center (conducted in more than one center) study, consisting of two periods: Period 1 is open-label (all people know the identity of the intervention), non-comparative dose titration phase and Period 2 is double blind (neither physician nor participant knows the treatment that the participant receives), positive control (fentanyl 3-day application transdermal patch is used as control drug) phase. In Period 1, fentanyl 1-day application transdermal patch 12.5 microgram per hour (mcg/hr) will be applied to chest, abdomen, upper arm or thigh and will be maintained for 2 days to ensure the safety of participants. Dose escalation or reduction will be allowed based on participant's condition from Day 3 to Day 11 and thereafter dose will be maintained from Day 11 to Day 13 with a maximum application dose of 100 mcg/hr. The total duration of Period 1 is 14 days (a total of 13 applications; including the day of final patch removal). Participants who met the predefined criteria at the end of dose titration phase will enter the double blind phase. In double blind phase, participants will receive either fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application transdermal patch or fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch at the same dose as used at the completion of Period 1. The duration of Period 2 is 10 days. Efficacy will primarily be evaluated by percentage of participants achieving dose titration success and change in mean visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.

Arms: arm 1: Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (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. Participants who met the predefined criteria at the end of Titration Phase enter the Double Blind Phase. arm 2: Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) 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. arm 3: Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 3-day application transdermal patch and placebo matched 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 with maximum applied dose of 100 mcg/hr for 10 days.
Interventions: intervention 1: Fentanyl 1-day transdermal patch (Titration Phase) intervention 2: Fentanyl 1-day transdermal patch (Double Blind Phase) intervention 3: Fentanyl 3-day transdermal patch (Double Blind Phase) intervention 4: Placebo intervention 5: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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. intervention 5: 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.

Protocol documents: