A Long-Term Study of JNS020QD (Fentanyl) in Chronic Pain Patients

• The primary endpoints: adverse events, laboratory tests, vital signs, ECG, Questionnaire of Opioid Withdrawal Symptoms and Dependence Questionnaire. Time measure: the first appilication of study drug to one week from final patch removal.
  

• Visual Analog Scale; pain intensity by categorical scale; quality of sleep; rescue treatment; Brief Pain Inventory; MOS Short-Form 36-Item Health Survey; physician's overall assessment, etc. Time measure is the same as the primary endpoints.
  

JNS020QD dosage is changed every day but its structure has the same matrix system as that of fentanyl matrix system. This is a multicenter, open-label, uncontrolled study. Safety and efficacy of JNS020QD will be determined in chronic pain patients. Application of JNS020QD will be started with the 12.5 mcg/hr product, and the dose will not be changed for at least 2 day (about 48 hours) after the initiation of application. In treatment period I, from day 2 (about 48 hours) after the initiation of patch application, the investigator or sub-investigator will confirm the patient's symptom and condition by medical examination, and appropriately increase the dose as needed. In treatment period II, the dose can be increased on 7th day before the day of medical examination (if the number of days where the rescue dose was used for 3 times or more per day is at least 4 days). In both treatment period I and II, the maximum dose is to be 300 mcg/hr. The study period consists of 3-14 days of screening period, 4 weeks of treatment period I, 48 weeks of treatment period II, 0-6 weeks of tapering period and 1 week of follow up period. The safety endpoints are adverse events, laboratory examinations, vital signs, pulse rate, ECG examination, Questionnaire of Opioid Withdrawal Symptoms and Dependence Questionnaire. The efficacy end points are Visual Analog Scale, subject's overall assessment, pain intensity by categorical scale, total painful time in 1 day, quality of sleep, rescue treatment, Brief Pain Inventory - Short Form, MOS Short-Form 36-Item Health Survey (version 2) and physician's overall assessment. Application of JNS020QD will be started with the 12.5 mcg/hr product, and the dose will not be changed for at least 2 days after the initiation of application. In treatment period II, the dose can be increased, of 7 days immediately before the day of medical examination, only if the number of days when the rescue dose was used 3 times or more per day is at least 4. In both treatment period I and II, the maximum dose is to be 300 mcg/hr.