A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Subjects aged >= 40 years with a BMI >= 25 and <= 40 kg/m2

• In the past, has been diagnosed with knee OA

• Radiographic evidence of OA in the study knee

Exclusion Criteria:

• A diagnosis of any other rheumatic disease

• Current conditions in the study knee that would confound efficacy

• Selected, traditional clinical safety and laboratory parameters