A Study of JNS020QD in Patients With Chronic Pain

• Proportion of patients who maintained the adequate analgesia [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
  Criteria for maintenance of adequate analgesia is defined as: 1) The daily dose of the study drug is constant during the 7 days in the maintenance period before completion of the maintenance period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 7 days in the maintenance period is ≤ 2 doses, and the change in the mean frequency of daily rescue dose from the baseline to endpoint is ≤+1.0 dose.
  
  

• Proportion of patients who achieve dose-adjustment [ Time Frame: Days 19-21 ] [ Designated as safety issue: No ]
  Criteria for achievement of dose-adjustment is defined as: 1) The daily dose of the study drug is constant during the 3 days before completion of the titration period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 3 days in the titration period is ≤2 doses; 4) daily doses of the study drug during the titration period does not exceed the maximum doses stipulated by the investigators.
  
  

The primary objective of this study is to evaluate the efficacy and safety of JNS020QD in patients with moderate to severe chronic pain who are switching from opioid analgesics. It will also evaluate the safety and efficacy of long-term treatment (52 weeks) after switching to JNS020QD. The study will enroll patients with moderate to severe chronic pain which is adequately controlled with a regular treatment with an opioid analgesic agent other than the study drug because these patients are considered appropriate to investigate the conversion ratio in switching from JNS020QD to other opioid analgesics, and to evaluate the efficacy and safety of the study drug. This is an open-label (all people know the identity of the intervention), uncontrolled (the study does not involve a control treatment), multicenter study. This study consists of Screening period (1 to 2 weeks), Period I (3-week titration period+ 1-week maintenance period), Period II (48 weeks long-term treatment period), tapering period (if required, 0 to 6 weeks), and follow-up period (1 week). JNS020QD is a transdermal system in which fentanyl base is incorporated directly into a single layer of pressure-sensitive high polymerized adhesive, and is changed once a day (every 24 hours). JNS020QD is available in 5 formulations containing fentanyl 0.84 mg, 1.7 mg, 3.4 mg, 5 mg, or 6.7 mg per system.. The study drug patch will be applied to the breast, abdomen, upper arm, femoral region, etc. exchanged daily and for consecutive 52 weeks.