A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
Condition: Pain; Diabetic Neuropathies; Neuralgia; Postherpetic Neuralgia
MeSH terms: Neuralgia; Diabetic Neuropathies; Neuralgia, Postherpetic; Chronic Pain
Intervention: Tapentadol; Placebo
Intervention description: Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.; Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Intervention MeSH terms: Tapentadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Chronic pain; Diabetic Neuropathic Pain; Neuralgia, Postherpetic; Tapentadol hydrochloride extended-release; JNS024ER; Placebo

Summary:

      The purpose of this study is to investigate the efficacy and safety of tapentadol
      extended-release (ER) tablets in Japanese participants with moderate to severe chronic
      (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the
      extremities related to diabetes-induced nerve damage) or postherpetic neuralgia (pain lasting
      after condition has healed).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with chronic pain due to painful diabetic neuropathy or postherpetic
             neuralgia continuing for at least 12 weeks before consent

          -  Participants with adjuvant analgesics (antidepressants, antiepileptics and diabetic
             peripheral neuropathy drugs) or non-opioid treatment and dissatisfied with current
             treatment (in sense of efficacy and/or safety) for at least consecutive 14 days during
             the 12 weeks before consent

          -  Participants have not experienced treatment with conventional opioids, except for the
             following cases: Short term use of opioid analgesics for treatment of post-operative
             acute pain more than 30 days before consent; and temporal use of codeine phosphate or
             dihydrocodeine phosphate for purposes other than pain relief (for example, for
             antitussive) more than 2 days before consent

          -  Mean pain intensity score of greater than or equal to 5 on an 11-point Numerical
             Rating Scale during 48 hours before consent and the Investigator or Sub-investigator
             considers that the participant should be treated with an opioid analgesic

          -  HbA1c within 4 weeks before consent less than or equal to 11percent (in participants
             with diabetic neuropathic pain)

        Exclusion Criteria:

          -  Participants have been treated or treated with a monoamine oxidase inhibitor within 14
             days before consent

          -  Current or a history of epilepsy or convulsive disorders or hypersensitivity to opioid
             analgesics

          -  Suggested of intracranial hypertension (for example, traumatic encephalopathy)

          -  Participants who have complicated condition with uncontrolled or clinically
             significant arrhythmia, or neuropsychiatric disorders

          -  Participants with moderately to severely impaired hepatic function, or severely
             impaired renal function