The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated CG5503 Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).
A Randomised Double-Blind, Placebo- and Active-Control, Parallel-Arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
- Osteoarthritis, Knee
Treatment, Randomised, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measures:
- Change from baseline of the average pain intensity over the last week of the Maintenance period at Week 12 or over the entire 12-week Maintenance period, depending on country requirements.
Secondary Outcome Measures:
- Incidence rates of treatment-emergent adverse events. Changes from baseline of the Western Ontario MacMaster Questionnaire (WOMAC), Sleep Questionnaire (SQ), 11-point NRS , and others, for a maximum timeframe of 20 weeks.
Eligibility & Criteria
- Ages Eligible for Study: 40 years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
- 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/or 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 numerical rater scale, calculated as the average pain intensity during the last 3 days prior to randomisation. Patients must meet all 4 assessments
- History of alcohol and/or drug abuse in Investigator’s judgement
- History of significant liver insufficiency
- 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
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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