The purpose of this study is to evaluate the conversion rate based on the number of participants achieving pain control and safety within 1 week after switching the opioid (morphine-like medications) analgesics (drug used to control pain), when tapentadol extended-release (ER) (JNS024ER) is orally administered to participants treated with around-the-clock opioid analgesics, for their moderate to severe (very serious, life threatening) chronic (lasting a long time) malignant (cancerous) tumor-related (a mass in a specific area) cancer (abnormal tissue that grows and spreads in the body) 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Tapentadol ER 100 to 400 milligram (mg) orally daily for 8 weeks (maximum up to 500 mg daily), as per Investigator's discretion.
Morphine SR 30 to 120 mg orally daily for 8 weeks (maximum up to 140 mg daily), as per Investigator's discretion.
Unnamed facility
Chiba, Japan
Unnamed facility
Hamamatsu, Japan
Unnamed facility
Ibaraki, Japan
Unnamed facility
Kanagawa, Japan
Unnamed facility
Katsushika-ku, Japan
Unnamed facility
Kobe, Japan
Unnamed facility
Kumamoto, Japan
Unnamed facility
Matsumoto, Japan
Unnamed facility
Matsuyama, Japan
Unnamed facility
Nagasaki, Japan
...and 12 more locations
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.
Time frame: Week 1
Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8
Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy
Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study.
Time frame: Baseline up to Week 8
Number of Participants With Patient Global Impression of Change (PGIC)
The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved".
Time frame: Week 1, 4 and 8
Total Number of Days of Rescue Medication Over Time
Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.
Time frame: Baseline up to Week 8
Number of Doses of Rescue Medication Over Time
Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.
Time frame: Baseline up to Week 8
Average Change From Baseline in Amount of Rescue Medication Over Time
Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8).
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.