Conditions: Chronic Pain
Keywords: Chronic pain Fentanyl Patch
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 142
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with chronic (lasting a long time) pain.

Detailed description:
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 4 periods: Screening period (3-14 days), Treatment period 1 (4 weeks), Treatment period 2 (48 weeks), Tapering period (0-6 weeks) and Follow-up period (1 week). Treatment will be initiated at 12.5 microgram per hour (mcg/hr). In both Treatment period 1 and 2, the dose will be increased as per the Investigator's discretion, ranging from 12.5 mcg/hr to 100 mcg/hr and the maximum application dose will be 300 mcg/hr. However, in Treatment period 2, the dose will be increased on 7th day before the day of medical examination (only if the participant used rescue treatment for minimum of 3 times per day for minimum of 4 days). The patch will be applied on areas including the chest, abdomen, upper arm and femoral region and replaced daily. Efficacy will primarily be evaluated by visual analog scale (VAS) score. The total duration of the study treatment will be 52 weeks. Participants' safety will be monitored throughout the study.

Arms:
arm 1: Fentanyl transdermal patch will be applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose will be increased as per Investigators' discretion in both treatment periods and the maximum applied dose will be 300 mcg/hr. Total duration of treatment is 52 weeks.

Interventions: intervention 1: Fentanyl
Intervention descriptions: intervention 1: Fentanyl transdermal patch will be applied daily starting at a dose of 12.5 mcg/hr, and up to 52 weeks. Dose will be increased as per Investigator's discretion.

Protocol document: