SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder
This clinical trial is to determine the safety and effectiveness of three injections of SUPARTZ (sodium hyaluronate) compared with saline (placebo) for the treatment of glenohumeral osteoarthritis of the shoulder. The trial contains two phases. In the first phase subjects are randomized to either SUPARTZ or placebo treatment. The second phase of the trial is open-label so all subjects will receive SUPARTZ injections only.
Glenohumeral Osteoarthritis of the Shoulder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multi-center, Randomized, Double-blind, Placebo Controlled Trial of SUPARTZ (Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain|
- Improvement in shoulder pain compared to subjects treated with placebo [ Time Frame: over a 26 week period ] [ Designated as safety issue: Yes ]
- Characteristic effects of pain improvement over a period of 26 weeks. [ Time Frame: over a 26 week period ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Supartz injection into the glenohumeral joint space.
Placebo Comparator: 2
Saline injection into the glenohumeral joint space.
Other Name: Saline
Phase III Multi-center, randomized study to determine the safety and efficacy of injections of SUPARTZ for Osteoarthritis of the Shoulder
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