A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain
Condition: Chronic Pain; Osteoarthritis; Low Back Pain
MeSH terms: Osteoarthritis; Back Pain; Low Back Pain; Chronic Pain
Intervention: Fentanyl; Placebo
Intervention description: One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.; Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 218.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Chronic pain; Osteoarthritis; Low back pain; Fentanyl; JNS020QD; Patch, transdermal; Opioid analgesics

Summary:

      The purpose of this study is to evaluate efficacy and safety of fentanyl in opioid-naive
      participants with osteoarthritis (disorder, which is seen mostly in older persons, in which
      the joints become painful and stuff) or low back pain who cannot obtain a sufficient
      analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants whose pain because of osteoarthritis or low back pain is continuing for
             at least 12 weeks prior to informed consent

          -  Participants 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
             participant at a certain dose (except the use on an as-needed base) on consecutive
             days

          -  Participants showing insufficient therapeutic efficacy of the non-opioid analgesic
             currently being used, and requiring a continuous opioid analgesic as per the
             investigator or sub-investigator

          -  Participants with an average pain intensity of 50 millimeter or more on the Visual
             Analog Scale (VAS) in 24-hour daily living prior to informed consent

          -  Participants who can be hospitalized to the 4th day after the initiation of titration
             period

        Exclusion Criteria:

          -  In cases of low back pain, participants with severe pain of lower extremities due to
             radiculopathy (a problem in which one or more nerves are affected) than that of low
             back pain, or participants with disc herniation (a medical condition affecting the
             spine due to trauma, lifting injuries, or idiopathic [unknown] causes) requiring an
             operation

          -  In cases of low back pain, participants with pain due to compression fracture

          -  Participants who had an operation that may affect the assessment within 30 days before
             informed consent

          -  Participants whose main cause of the pain to be assessed is considered attributable to
             psychogenic pain (physical pain that is caused, increased, or prolonged by mental,
             emotional, or behavioral factors)

          -  Participants with asthma, bradyarrhythmia (slow irregular heart beat) and severe
             respiratory function disorders