A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Condition: Pain; Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Intervention: Tapentadol ER (100 to 250 mg twice daily); Matching Placebo (twice daily); Oxycodone CR (20 to 50 mg twice daily)
Intervention description: 50, 100, 150, 200, 250 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance); Matching Placebo during 15 weeks (3 weeks titration and 12 weeks maintenance); 10, 20, 30, 40, 50 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)
Intervention MeSH terms: Oxycodone; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 990.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Knee; Pain Assessment; CG5503 PR; Centrally acting analgesic; Placebo; Oxycodone; Chronic Pain due to knee Osteoarthritis; Tapentadol

Summary:

      The purpose of this study is to evaluate whether tapentadol (CG5503) prolonged-release (PR)
      tablets at doses of 100-250 mg twice daily provide a better pain relief in patients with
      moderate to severe chronic pain due to osteoarthritis of the knee than a placebo (a
      medication without active substance). In addition the tolerability of CG5503 PR will be
      assessed. One third of the patients will receive CG5503 and one third will receive placebo.
      For further comparison one third of the patients will receive oxycodone controlled release
      (CR) at doses of 20-50 mg twice daily which is an active approved pain medication. Please
      note that tapentadol ER (Extended Release) and tapentadol PR (Prolonged Release) are
      identical and used interchangeably. This is due to United States of America and European
      naming conventions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with osteoarthritis of the knee based on the American College of
             Rheumatology (ACR) criteria and functional capacity class of I- III;

          -  Patients taking analgesic medications for at least 3 months prior to screening and
             dissatisfied with their current therapy;

          -  Patients requiring opioid treatment must be taking daily doses of opioid- based
             analgesic, equivalent to <160 mg of oral morphine;

          -  Baseline score of >=5 on an 11-point numeric rating scale, calculated as the average
             pain intensity during the last 3 days prior to randomization.

        Exclusion Criteria:

          -  History of alcohol and/or drug abuse in Investigator's judgment;

          -  Chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past
             3 months;

          -  Life-long history of seizure disorder or epilepsy;

          -  History of malignancy within past 2 years, with exception of basal cell carcinoma that
             has been successfully treated;

          -  Uncontrolled hypertension;

          -  Patients with severely impaired renal function;

          -  Patients with moderate to severely impaired hepatic function or with laboratory values
             reflecting inadequate hepatic function,

          -  Treatment with neuroleptics, monoamine oxidase inhibitors, serotonin norepinephrine
             reuptake inhibitors (SNRI), tricyclic antidepressants, anticonvulsants, or
             anti-parkinsonian drugs, treatment with any other analgesic therapy than
             investigational medication or rescue medication during the trial.