SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

A Multi-center, Randomized, Double-blind, Placebo Controlled Trial of SUPARTZ (Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain

This clinical trial is to determine the safety and effectiveness of three injections of SUPARTZ (sodium hyaluronate) compared with phosphate buffered saline (PBS) for the treatment of glenohumeral osteoarthritis of the shoulder. The trial contains two phases. Phase I is 26 weeks, double blinded, and subjects are randomized to either SUPARTZ or PBS treatment. Phase II is 26 weeks (total 52 weeks) and open-label so all subjects will receive SUPARTZ injections only.

Phase 3 Study: Multi-center, randomized, double blinded, two phase study to determine the safety and efficacy of 3 injections of SUPARTZ for Osteoarthritis of the Shoulder

Inclusion Criteria:

• Glenohumeral Osteoarthritis (OA) confirmed by radiograph
• Limitation of shoulder motion in at least one direction
• Retained active range of motion of at least 30% in all directions

Exclusion Criteria:

• Full thickness rotator cuff tear or rotator cuff tendinopathy
• Frozen shoulder
• Female who is pregnant or lactating