A Study to Evaluate the Effectiveness and Safety of Multiple Doses of Tapentadol(CG5503) in Patients Awaiting Joint Replacement Surgery
Condition: Osteoarthritis; Pain Assessment; Arthralgia
MeSH terms: Osteoarthritis; Arthralgia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate in patients who are eligible for elective primary
      total or partial joint replacement of the hip or knee due to chronic osteoarthritis the
      efficacy (level of pain control) of CG5503 over 5 and 10 days compared with placebo, and to
      assess the safety and tolerability of multiple doses of CG5503 IR patients.
    

Detailed description: 
      CG5503 is a centrally active pain-relieving drug being investigated for the treatment of
      acute and chronic pain. This study was designed to assess the safety and tolerability of
      CG5503 IR in patients who need joint replacement of the hip or knee due to chronic
      osteoarthritis. This is a double-blind study, i.e., neither patients nor investigators will
      know what treatment is given. Before the start of the 10 day double-blind phase, each patient
      will be screened for eligibility and eligible patients will be randomly assigned to receive
      either CG5503 IR, oxycodone IR, or placebo (i.e., no active drug). All patients will take
      their treatment by mouth every 4 to 6 hours during waking hours. A total of 60 doses (up to 6
      doses per day) of study treatment will be provided for each patient during the 10-day
      treatment phase. The study treatment will be dispensed on Day 1, and patients will take the
      first dose in the evening of the same day. The effectiveness of study treatment (CG5503 IR,
      oxycodone, or placebo) will be assessed using several measures, including 11 Point Pain
      Numerical Rating Scale, 5-Point Relief Numerical Rating Scale, and Patient Global Impression
      of Change. Using these scales, patients will indicate their pain intensity level, pain relief
      level, and overall status of their well-being. Safety and tolerability will be assessed using
      physical examination, monitoring of adverse events, clinical and laboratory measures, and 12
      lead ECG results. The null hypothesis for the study is that all CG5503 IR dosage efficacy
      results are equal to placebo based on the 5-day SPID in the treatment of chronic pain caused
      by osteoarthritis. The alternative study hypothesis is that at least 1 CG5503 IR dose effect
      will be different from placebo effect. CG5503 IR 50 mg, 75 mg of the base, 10 mg oxycodone or
      placebo for 10 days taken by mouth every 4 to 6 hours during waking hours. Patients
      randomized to CG5503 IR 75 mg group will receive CG5503 IR 50 mg on Day 1 and 75 mg on Day 2
      to 10. All doses of study treatment should be taken with approximately 120 mL of water with
      or with food.
    

Intervention name(s): CG5503 IR; tapentadol
Intervention type(s): Drug
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Osteoarthritis; tapentadol; knee-replacement; hip replacement; pain