A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants
Condition: Neoplasms
Intervention: Tapentadol ER; Morphine SR
Intervention description: 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.
Intervention MeSH terms: Morphine; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Tapentadol; Tumor related pain; Opioid; Cancer related pain; Morphine

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with documented clinical diagnosis (determination of the cause of a
             medical problem) of any type of cancer (abnormal tissue that grows and spreads in the
             body)

          -  Participants with mean 24-hour Numerical Rating Scale (NRS) score (11-point NRS used
             to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as
             you can imagine) during 3 days (Day -4 to Day -2) before randomization (study drug
             assigned by chance) less than 4.0

          -  Women must be post-menopausal, surgically sterile, or before entry and throughout the
             study practicing an effective method of birth control

          -  Participants using immediate-release (IR) morphine hydrochloride (HCl) or oxycodone
             HCl hydrate as rescue medication (rescue medications are medicines that may be
             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) for breakthrough pain

          -  Participants treated with around-the-clock opioid (morphine-like medications) therapy
             for 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 using one of the following opioid
             analgesics (drug used to control pain) before randomization: morphine SR tablet less
             than or equal to 120 milligram (mg) per day, oxycodone hydrochloride controlled
             release (CR) tablet: 15 mg to 80 mg per day, durotep MT (fentanyl transdermal [through
             the skin] matrix) patch less than or equal to 8.4 mg per patch, fentos tape less than
             or equal to 4 mg per tape, or oneduro patch less than or equal to 3.4 mg per patch

        Exclusion Criteria:

          -  Participants with complicated uncontrolled/clinically significant arrhythmia (uneven
             heart beat)

          -  Participants who had received rescue doses 3 times or more daily within 3 days (Day -4
             to Day -2) before the randomization

          -  History of surgery intended for the cure of the primary disease or for the treatment
             of cancer pain within 28 days before screening

          -  Participants who had application of radiotherapy (treatment of cancer using x-rays),
             nerve block, or stimulation analgesia within 7 days before screening

          -  Participants with known allergies (over sensitivity to a substance), hypersensitivity,
             or intolerance to opioid analgesics or its excipients