This Phase 3 study is a two-arm, double-blind study to:~compare the analgesic efficacy and safety of the flexible regimen of Q8003 (6 mg/4 mg up to 24 mg/16 mg) administered every 4-6 hours over a 48-hour Treatment Period versus low dose Q8003 (every 4-6 hours 3 mg/2 mg with a 6 mg/4 mg loading dose) to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty.~to evaluate the efficacy and safety of Q8003 when administered in the Voluntary Extension Period starting at 48 hours after the initial dosing and extending up to Day 12.
This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty