Trial Information

A Randomized, Double-Blind, Active Controlled, Optimal Dose Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended Release (ER) in Japanese and Korean Subjects With Moderate to Severe Chronic Malignant Tumor Related Cancer Pain

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.