A Confirmatory Study of JNS020QD (Fentanyl) in Patients With Osteoarthritis or Low Back Pain

The purpose of this study is to evaluate efficacy and safety of JNS020QD (fentanyl) in opioid-naive patients with osteoarthritis or low back pain who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analgesics.

JNS020QD (fentanyl) used the same matrix system as that of 3-day fentanyl matrix system but changes every day. This is a multicenter, placebo-controlled, double-blind (neither the patient nor the physician knows the assigned study drug), group-comparison, randomized (patients assigned study drug by chance), withdrawal study. Efficacy and safety of JNS020QD (fentanyl) will be confirmed in opioid-naive patients with osteoarthritis or low back pain that is not sufficiently treated with non-opioid analgesics in the study. Application of JNS020QD (fentanyl) will be started with the 12.5 mcg/hr product, and the dose will not be changed for at least 2 days (about 48 hours) after the initiation of application. The dose of JNS020QD (fentanyl) will be increased by 12.5 mcg/hr at one time if needed, and the maximum dose is to be 50 mcg/hr. Of patients who were transferred to treatment period I and had application of JNS020QD (fentanyl) for 10 to 29 days, those who meet all of the following criteria can be transferred to treatment period II (double-blind period): (1) Patients with a mean VAS score of = 45 mm during 3 days before the end of treatment period I (titration period), (2) Patients with an improvement of > 15 mm in the mean VAS score during 3 days before the end of treatment period I (titration period) compared with that during 3 days before the end of screening period, (3) Patients whose dose of JNS020QD (fentanyl) application is certain during 3 days before the end of treatment period I (titration period), (4) Patients whose number of rescue doses during 3 days before the end of treatment period I (titration period) is <= twice/day. Then, the patients who complete the treatment period I and meet the eligibility criteria for the treatment period II (double-blind period) will be randomly assigned to the JNS020QD (fentanyl) treatment group or placebo treatment group to continue the final application dose in treatment period I (titration period). Application of patches in treatment period II (double-blind period) will be conducted according to the prescribed method based on the final application dose in treatment period I. The study period consists of 3-14 days of screening period, 10-29 days of treatment period I, 12 weeks of treatment period II, 0-2 weeks of tapering period and 1 week of follow up period. The primary end point is time (number of days) from the initial day of patch application in treatment period II to discontinuation due to insufficient analgesic efficacy. The safety evaluations are adverse events, laboratory examinations, vital signs, Electrocardiogram examination, Questionnaire of Opioid Withdrawal Symptoms and Dependence Questionnaire. As pharmacokinetic endpoints, serum fentanyl concentrations are measured. Patients receive initially 12.5 mcg/h of JNS020QD (fentanyl), subsequently the dose of JNS020QD (fentanyl) can be increased up to 50 mcg/h in Period I. The duration of Period I is 10 to 29 days. In Period II (double-blind period), the assigned patch is applied for 12 weeks at the same dose as used at the end of Period I.

Inclusion Criteria:

• Patients whose pain due to osteoarthritis or low back pain are continuing for at least 12 weeks prior to informed consent
• Patients who are continuously taking a non-opioid analgesic at the normal highest dose or more for at least 14 consecutive days prior to informed consent, or patients who are continuously taking a non-opioid analgesic at a certain dose (except the use on an as-needed base) on consecutive days although the dose is less than the normal highest dose because of being unable to receive treatment at the normal highest dose or more for medical reasons such as safety
• Patients who are considered by the investigator or sub-investigator to show an insufficient therapeutic efficacy of the non-opioid analgesic currently being used, and to require a continuous opioid analgesic treatment.

Exclusion Criteria:

• In cases of low back pain, patients with more severe pain of lower extremities due to radiculopathy than that of low back pain, or patients with disc herniation requiring an operation
• In cases of low back pain, patients with pain due to compression fracture
• Patients who had an operation that may affect the assessment within 30 days before informed consent
• Patients whose main cause of the pain to be assessed is considered attributable to psychogenic pain
• Patients with severe respiratory function disorders.