A Randomized, Open-Label, Parallel-Arm, Optimal Dose-Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended-Release (ER) in Japanese Subjects Treated With Around-the-Clock Opioid Analgesics for Their Moderate to Severe Chronic Malignant Tumor- Related Cancer Pain
This is a randomized (study drug assigned by chance), open-label (a medical research study
in which participants and researchers are told which treatments the participants are
receiving, "unblinded"), parallel-arm (participants receive 1 of 2 possible interventions
during the same time frame throughout the study), optimal dose-titration, multicenter (when
more than one hospital or medical school team work on a medical research study) study
evaluating the conversion rate based on the number of participants achieving pain control
and safety within 1 week after switching from an ongoing around-the-clock opioid analgesic
(morphine sustained-release [SR], oxycodone controlled-release, or fentanyl transdermal) to
tapentadol ER or morphine SR, for their moderate to severe chronic, malignant tumor-related
cancer pain. The study consists of 2 periods: 1 to 2 week screening period, followed by
8-week open-label treatment period. During the study period, participants will be
hospitalized or outpatient. However, it is preferable to be hospitalized 1 week before and 1
week after to evaluate efficacy before and after switching opioids for securing
participants' safety. At Day 1, participants will receive either tapentadol ER or morphine
SR twice daily. During the treatment period, the dose of the study drug will be titrated to
the participant's optimal dose. The participants will receive either tapentadol ER or
morphine SR twice daily for 8 weeks. The maximum dose allowed for tapentadol ER will be 500
milligram (mg) daily or morphine SR 140 mg daily throughout the study. Efficacy is primarily
evaluated using pain intensity score on an 11 point Numerical Rating Scale (an 11-point NRS
is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine).
Participants' safety will also be monitored.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Who Achieved Pain Control
Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day.
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Japan: Pharmaceuticals and Medical Devices Agency