An Efficacy and Safety Study of Fentanyl (JNS020QD) in Participants With Cancer Pain
Condition: Pain; Cancer
MeSH terms: Cancer Pain
Intervention: Fentanyl
Intervention description: Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is fixed for next 3 days that is Day 10 (end of treatment period).
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Pain; Cancer; Fentanyl; JNS020QD

Summary:

      The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day
      transdermal patch (patch containing a drug that is put on the skin so the drug will enter the
      body through the skin) in participants switched from morphine preparations, oral oxycodone
      preparations, fentanyl citrate injection or fentanyl patch for cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants receiving any of the following drugs at a stable dose for at least 3 days
             (or 9 days in case of fentanyl patch) before the start of application of the study
             drug: Morphine preparations at less than or equal to 314 milligram per day (mg/day) as
             an oral morphine equivalent dose of less than or equal to 157 mg/day for suppository
             or less than or equal to 104 mg/day for injection, oral oxycodone preparations at less
             than or equal to 209 mg/day, fentanyl citrate injection at less than or equal to 2.0
             mg/day, fentanyl patch less than or equal to 7.5 mg

          -  Participants assumed to use not more than 2 rescue doses (dose of a fast-acting opioid
             analgesic except fentanyl preparations used for lack of analgesic effect) daily for at
             least 3 days before the start of application of the study drug

          -  Participants showing a pain intensity of less than or equal to 34 millimeter (mm) on a
             100-mm visual analog scale (VAS)

          -  Participants who have an established diagnosis of cancer and are notified of the
             disease

          -  Participants who can be hospitalized during the course of application of the study
             drug

        Exclusion Criteria:

          -  Participants with impaired respiratory function due to chronic lung disease or others

          -  Participants with asthma (breathing disorder in which there is wheezing and difficulty
             in breathing or participants with bradyarrhythmia (slow, irregular heartbeats)

          -  Participants with following measurements indicative of hepatic or renal impairment
             during the pre-treatment observation period: Aspartate transaminase (AST) greater than
             5 times the upper limit of reference range, Alanine transaminase (ALT) greater than 5
             times the upper limit of reference range, serum creatinine greater than 3 times the
             upper limit of reference range

          -  Participants with any cerebral damage, such as brain tumor, accompanied by increased
             intracranial pressure, disturbance of consciousness, coma, or respiratory disturbance

          -  Participants with a history of hypersensitivity to fentanyl or other opioid analgesics