A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
Condition: Pain
MeSH terms: Neoplasms; Cancer Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as
      JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone
      Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant,
      tumor-related cancer pain.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), double-blind (neither the patient nor
      the study staff will know the identity of the study drug assigned to each patient),
      multicenter study to evaluate the safety and efficacy of orally (by mouth) administered
      R331333 (referred to as JNS024 extended release [ER] capsules or CG5503) in dosages of 25 mg
      to 200 mg twice daily compared with orally administered capsules of oxycodone controlled
      release (CR) in dosages of 5 mg to 40 mg twice daily over 4 weeks in Japanese and Korean
      patients with moderate to severe chronic malignant tumor-related cancer pain who require
      around-the-clock opioid therapy (treatment with narcotic analgesics or pain relievers) and
      are dissatisfied with the pain relief they are experiencing from current treatment. The
      active control, oxycodone CR, is being used in this study because it is an opioid analgesic
      approved for the treatment of moderate to severe pain. Approximately 212 Japanese patients
      and approximately 100 Korean patients who meet screening criteria for the study will be
      enrolled in the study and will enter the titration period of the study where they will
      receive a starting dosage of either JNS024 ER 25 mg twice daily or oxycodone CR 5 mg twice
      daily. The dose of study drug for each patient will be titrated (increased) to the optimal
      dose until sufficient analgesia (pain relief) is achieved (ie, up to a maximum dose of JNS024
      ER 200 mg twice daily or Oxycodone CR 40 mg twice daily). When the dosage of study drug is
      increased, the safety will be confirmed at the study visit or by telephone on the day after
      the dose is increased. Once an optimal dose of study drug is determined, the patient will
      continue to receive that dose during the maintenance period in the study. Patients will
      participate in the study for total of approximately 6 weeks; during this time patients will
      receive study drug for 4 weeks (titration and maintenance periods combined). During the
      study, if a patient experiences breakthrough pain (pain that occurs for short periods of time
      between doses of study drug), treatment with rescue medication (morphine immediate release
      [IR] 5 mg) will be given. In addition, patients will be allowed to continue to take stable
      doses of non-opioid analgesics (non-narcotic pain medications for mild to moderate pain) that
      they were taking at the time of study entry and may reduce the dosage or discontinue their
      use during the study. During the study, blood samples will be collected from patients at
      protocol-specified time points to determine the concentration of study drug after
      administration. The safety of patients will be monitored during the study by evaluating
      adverse events and findings from clinical laboratory tests, physical examinations, vital
      signs measurements, and electrocardiogram (ECG) measurements reported. The primary outcome
      measure in the study will be the change from baseline to the last 3 days of study drug
      administration in the average pain intensity score using an 11 point numerical rating scale
      (NRS). Patients will receive R331333 (referred to as JNS024 ER or CG5503) by mouth with or
      without food at a starting dose of 25 mg twice daily to be increased if necessary to a
      maximum dose of 200 mg twice daily for a total of 4 weeks (titration and maintenance periods
      combined) OR double-blind oxycodone CR by mouth with or without food at a starting dose of 5
      mg twice daily to be increased if necessary to a maximum dose of 40 mg twice daily for a
      total of 4 weeks.
    

Intervention name(s): Oxycodone CR; R331333 (referred to as JNS024 ER or CG5503)
Intervention type(s): Drug; Drug
Intervention description(s): One 5 mg to 40 mg capsule twice daily for 4 weeks.; One 25 mg to 200 mg capsule twice daily for 4 weeks.
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pain; R331333 (JNS024ER, CG5503), tapentadol (NUCYNTA); Opioid analgesic; Oxycodone CR (OXYCONTIN CR); Chronic malignant tumor related cancer pain