An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants
Condition: Pain; Low Back Pain; Back Pain; Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Back Pain; Low Back Pain; Chronic Pain
Intervention: Tapentadol Hydrochloride; Placebo
Intervention description: Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.; Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.
Intervention MeSH terms: Tapentadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Pain; Low Back Pain; Back Pain; Osteoarthritis, Knee; Tapentadol; Tapentadol Hydrochloride Extended Release

Summary:

      The purpose of this study is to evaluate the efficacy, safety and to explore the
      pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the
      body and how they are removed from the body over time) of tapentadol hydrochloride extended
      release (ER) tablets in Japanese participants with moderate to severe chronic pain due to
      osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back
      pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with chronic pain due to osteoarthritis of knee or low back pain
             continuing for at least 12 weeks before informed consent

          -  Participants who did not achieve adequate analgesia (pain control) with routine
             treatment with an oral non-opioid analgesic (drug used to control pain) at its usual
             upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during
             the 12 weeks before informed consent

          -  Participants who have not experienced treatment with conventional opioids, except for
             short term use of opioid analgesics for treatment of post-operative acute pain more
             than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine
             phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days
             before informed consent

          -  Participants with average pain intensity score of greater than or equal to 5 on an
             11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are
             considered requiring opioid treatment by the Investigator

          -  Participants who are able to visit the medical institutions throughout the study
             period

        Exclusion Criteria:

          -  Participants who are taking a monoamine oxidase inhibitor within 14 days before
             informed consent

          -  Participants with current or a history of epilepsy or seizure disorders

          -  Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)

          -  Participants with uncontrolled or clinically significant arrhythmia (irregular heart
             rate)

          -  Participants with moderate to severe liver dysfunction or severe renal dysfunction