A Multi-center, Randomized, Double-blind, Placebo Controlled Trial of SUPARTZ (Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bioventus LLC
- Enrollment
- 300
- Primary Endpoint
- Visual Analogue Scale (VAS: 0-100) for Pain on Movement
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Supartz
SUPARTZ® 3 injections over 2 weeks
Intervention: SUPARTZ® (Device)
Phosphate Buffered Saline
Phosphate Buffered Saline 3 injections over 2 weeks
Intervention: Phosphate Buffered Saline (Device)
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS: 0-100) for Pain on Movement
Time Frame: Ph1: weeks 7 - 26
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
Secondary Outcomes
No secondary outcomes reported