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SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

This study has been completed.
Information provided by (Responsible Party):
Bioventus LLC Identifier:
First received: May 24, 2007
Last updated: March 17, 2015
Last verified: July 2013
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.

Condition Intervention Phase
Osteoarthritis of the Shoulder Device: SUPARTZ Device: Phosphate Buffered Saline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

Resource links provided by NLM:

Further study details as provided by Bioventus LLC:

Primary Outcome Measures:
  • Improvement in shoulder pain compared to subjects treated with placebo [ Time Frame: over a 26 week period ]

Secondary Outcome Measures:
  • Characteristic effects of pain improvement over a period of 26 weeks. [ Time Frame: over a 26 week period ]

Enrollment: 256
Study Start Date: May 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Supartz
Supartz injection into the glenohumeral joint space.
Placebo Comparator: Phosphate Buffered Saline
Phosphate Buffered Saline
Device: Phosphate Buffered Saline
Saline injection into the glenohumeral joint space.
Other Name: Saline

Detailed Description:
Phase III Multi-center, randomized study to determine the safety and efficacy of injections of SUPARTZ for Osteoarthritis of the Shoulder

Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Glenohumeral OA confirmed by radiograph
  • Limitation of shoulder motion in at least one direction

Exclusion Criteria:

  • Full thickness rotator cuff tear or rotator cuff tendonopathy
  • Frozen shoulder
  • Female who is pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00479687

Sponsors and Collaborators
Bioventus LLC
Principal Investigator: Scott Sledge, MD Northeast Orthopedics - Unlimited Research
Principal Investigator: Charles Birbara, MD Clinical Pharmacology Study Group
  More Information

Responsible Party: Bioventus LLC Identifier: NCT00479687     History of Changes
Other Study ID Numbers: SHO-0106
Study First Received: May 24, 2007
Last Updated: March 17, 2015

Keywords provided by Bioventus LLC:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on September 19, 2017