SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Osteoarthritis of the Shoulder

Intervention / Treatment
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* Device: SUPARTZ®
* Device: Phosphate Buffered Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supartz<br>SUPARTZ® 3 injections over 2 weeks | Device: SUPARTZ®<br>* Three Supartz injections over 2 weeks into the glenohumeral joint space.<br>|
| Placebo Comparator: Phosphate Buffered Saline<br>Phosphate Buffered Saline 3 injections over 2 weeks | Device: Phosphate Buffered Saline<br>* Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS: 0-100) for Pain on Movement | Visual Analogue Scale (VAS) for pain on (shoulder) movement with a range of 0 to100; where 0=No pain at all and 100=Pain as bad as it can be. Q: How bad is the pain in your study shoulder with activity or movement? (For example, when putting on a coat, sleeping on your study shoulder side, combing your hair, reaching a high shelf, etc.) Reported is a single Least square mean point estimate over the 7-26 week time interval using the assessments collected at weeks 7, 13, 20, and 26 | Ph1: weeks 7 - 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Shoulder, Hyaluronic Acid (HA)