SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder
CompletedNot applicableNCT00479687
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Multi-center, Randomized, Double-blind, Placebo Controlled Trial of SUPARTZ (Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain
- Conditions
- Osteoarthritis of the Shoulder
- Interventions
- Device: SUPARTZ®
- Device: Phosphate Buffered Saline
- Sponsor
- Bioventus LLC
- Start date
- 2007-05
- Primary completion
- 2009-10
- Sex
- All
- Age range
- from 35 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00479687