An Efficacy and Safety Study of Fentanyl in Participants With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Fentanyl
Intervention description: 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.
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Chronic pain; Fentanyl Patch

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants whose medication for chronic pain meets one of the criteria among a to e
             (2 or more types of opioid analgesics must not be used): a) Participants who are
             taking non-opioid analgesic at the normal highest dose or more for at least 14
             consecutive days during 12 weeks before the informed consent, but were not
             continuously taking the non-opioid analgesic during 14 days before the informed
             consent for medical reasons such as safety b) Participants who are continuously taking
             an additional analgesic with a certain dosage and administration for at least 14
             consecutive days before the informed consent c)Participants who are continuously
             taking codeine phosphate or dihydrocodeine phosphate less than 270 milligram (mg)
             daily (except for rescue treatment) for at least 14 consecutive days before the
             informed consent d) Participants who are continuously taking codeine morphine
             hydrochloride of oral morphine equivalent dose of less than 45 mg daily (except for
             rescue treatment) for at least 14 consecutive days before the informed consent (less
             than 30 mg daily for suppositories and less than 15 mg daily for injections) e)
             Participants who are continuously taking fentanyl citrate injection of less than 0.3
             mg daily (except for rescue treatment) for at least 14 consecutive days before the
             informed consent

          -  Participants with chronic pain continuing for at least 12 weeks before informed
             consent

          -  Participants with an average pain intensity of greater than or equal to 50 millimeter
             (mm) on the Visual Analog Scale in 24-hour daily living before informed consent

          -  Participants who can be hospitalized to the 4th day after the initiation of patch
             application

          -  Participants who were given a sufficient explanation about the investigational product
             and the study and gave their own consent to participate in the study

        Exclusion Criteria:

          -  Participants whose main cause of the pain to be assessed is considered attributable to
             psychogenic pain

          -  Participants with severe respiratory function disorders

          -  Participants with asthma (breathing disorder in which there is wheezing and difficulty
             breathing) and bradyarrhythmia (slow, irregular heartbeats)

          -  Participants with hepatic dysfunction function such as fulminant hepatitis
             (inflammation of the liver) and liver cirrhosis (serious liver disorder in which
             connective tissue replaces normal liver tissue, and liver failure often occurs), or
             renal impairment such as nephritic syndrome, acute renal failure, and chronic renal
             failure

          -  Participants with organic disorder in the brain such as brain tumor who have any of
             these symptoms: intracranial pressure increased, consciousness disturbance or coma and
             respiratory disorder