Conditions: Osteoarthritis
Keywords: knee Osteoarthritis Disease Modifying Osteoarthritis Drug
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1457
Healthy volunteers: no

Brief summary:
The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.

Detailed description:

Arms:
arm 1: High dose active comparator arm 2: Low dose active comparator arm 3: Placebo comparator to be used for control purposes

Interventions: intervention 1: SD-6010 intervention 2: SD-6010 intervention 3: Placebo
Intervention descriptions: intervention 1: 200 mg tablets once a day for 2 years intervention 2: 50 mg tablets once a day for 2 years intervention 3: Placebo tablets once a day for 2 years

Protocol document: