Conditions: Osteoarthritis, Knee Pain
Keywords: Chronic Pain Osteoarthritis, Knee tapentadol Pain Assessment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1030
Healthy volunteers: no

Brief summary:
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (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).

Detailed description:
The primary objective of this randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows the study medication) , phase III, placebo and active controlled trial is to evaluate the efficacy and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain from osteoarthritis (OA) of the knee. The study is being conducted for registration and approval of tapentadol (CG5503) in the US and outside the US. The trial will consist of five periods: screening (to assess eligibility) , washout (3-7 days with determination of a baseline pain intensity), titration (of dose over 3 weeks to the optimal individual level) , maintenance (investigational drug intake for 12 weeks with adjustments allowed), and follow-up (2 weeks post treatment discontinuation). The study hypothesis is that the study drug will be more effective than placebo in reducing patients pain intensity. The Secondary objectives include the collection of pharmacokinetic (related to how the body uses the drug) information for dose verification. The trial objectives will be assessed by comparing the baseline pain level to the level of week 12 of the maintenance phase. This will be done by looking at the patient's pain diary information. Titrate tapentadol (CG5503) ER (extended release) 50mg to patient's optimal dose ranging between 100mg and 250mg twice a day; Oxycodone CR (controlled release) 10mg to 50mg twice a day; Placebo (no active ingredients). All doses of trial treatment will be taken orally with approximately 120 mL of water with or without food for a maximum timeframe of 15 weeks.

Arms:
arm 1: tapentadol (CG5503) 50 100 150 200 250mg twice a day (BID) during 15 weeks arm 2: oxycodone 10 20 30 40 50mg twice a day (BID) during 15 weeks arm 3: placebo matching placebo twice a day (BID) during 15 weeks

Interventions: intervention 1: oxycodone intervention 2: placebo intervention 3: tapentadol (CG5503)
Intervention descriptions: intervention 1: 10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks intervention 2: matching placebo twice a day (BID) during 15 weeks intervention 3: 50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks

Protocol document: