Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants
Condition: Pain; Cancer
MeSH terms: Cancer Pain
Intervention: Tapentadol PR
Intervention description: Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days.
Intervention MeSH terms: Tapentadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Pain; Cancer; Tapentadol

Summary:

      The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the
      drug is absorbed in the body, distributed within the body, and how it is removed from the
      body over time; explores what the body does to the drug) of tapentadol prolonged release
      (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and
      spreads in the body until it kills) pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Opioid switching participants should meet the following criteria from a to c: a)
             Participants with cancer pain b) previously were on opioid medications (morphine
             sustained release preparations [120 milligram per day {mg/day} or less], oxycodone
             hydrochloride sustained release tablets [80 mg/day or less], fentanyl transdermal
             [through the skin] application system [4.2 mg or less]) c) had achieved adequate pain
             control with opioid therapy

          -  Opioid naive participants should meet the following criteria from a to b: a)
             Participants with cancer pain b) should not have received any pain control therapy
             with opioids (excluding narcotic antagonist analgesics [drug used to control pain])

          -  Definite diagnosis of any type of cancer, which has been notified to the participant

          -  Participants who can be hospitalized during the treatment period

          -  Participant who can record 11 point Numerical Rating Scale (NRS) and 100 millimeter
             (mm) Visual Analog Scale (VAS) scores appropriately throughout the study

        Exclusion Criteria:

          -  Participants with bradyarrhythmia (slow, irregular heartbeats)

          -  History of mild or moderate traumatic (causing damage, like a toll used to crush
             tissue) encephalopathy, cerebral (having to do with the cerebrum) infarction (death of
             tissue because of lack of blood supply) or transient ischemic (decreased oxygen in a
             tissue [usually because of decreased blood flow]) attack within 1 year before informed
             consent

          -  Previous or concurrent epilepsy (seizure disorder) or convulsive diseases accompanied
             by disturbance of consciousness

          -  Previous or concurrent alcohol dependence or narcotic abuse

          -  History of active hepatitis (inflammation of the liver) B or C within 3 months before
             informed consent