A Phase III Study of JNS020QD in Cancer Pain Patients - Evaluation of the Efficacy and Safety of JNS020QD Switched From Opioid Analgesics
This is an open-label (all people know the identity of the intervention), multi-center
(conducted in more than one center) and non-comparative study of fentanyl one-day
transdermal patch. The study consists of 3 periods: Pre-treatment observation period (4-7
days), Treatment period (10 days) and Follow-up period (2 days). Treatment will be initiated
at 12.5 microgram per hour (mcg/hr) and the initial dose of fentanyl will be determined
based on the daily dose of the opioid analgesic taken by the participant before entering the
study and will be maintained for 2 days to ensure safety of participants. Dose escalation or
reduction will be as per the Investigator's discretion from Day 3 to Day 7 and thereafter
dose will be again maintained from Day 7 to Day 9, ranging from 12.5 mcg/hr-100 mcg/hr and
the maximum application dose will be 300 mcg/hr. The patch will be applied on areas
including the chest, abdomen, upper arm or thigh and will be replaced daily for 10 days (a
total of 9 applications; including the day of final patch removal). Efficacy will primarily
be evaluated by visual analog scale (VAS) score. Participants' safety will be monitored
throughout the study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Achieving Pain Control
Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.
Day 10 or early discontinuation (ED)
Janssen Pharmaceutical K.K., Japan Clinical Trial
Janssen Pharmaceutical K.K.
Japan: Pharmaceuticals and Medical Devices Agency