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
Pain, Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Pain focused on measuring Osteoarthritis, Knee, Pain Assessment, CG5503 PR, Centrally acting analgesic, Placebo, Oxycodone, Chronic Pain due to knee Osteoarthritis, Tapentadol
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Active Comparator
Matching Placebo (twice daily)
Tapentadol ER (100 to 250 mg twice daily)
Oxycodone CR (20 to 50 mg twice daily)
The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions.
The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.
The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.