A Phase II/III Study of JNS020QD in Cancer Pain Patients - A Dose-Finding, Double-Blind Study of JNS020QD Compared With JNS005 in Patients Previously Untreated With Opioid Analgesics
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Percentage of Participants Achieving Dose Titration Success
Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain.
Day 14 or early discontinuation (ED)
Janssen Pharmaceutical K.K., Japan Clinical Trial
Janssen Pharmaceutical K.K.
Japan: Pharmaceuticals and Medical Devices Agency