SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00479687
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Bioventus LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis of the Shoulder Device: SUPARTZ Device: Phosphate Buffered Saline Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
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
Study Start Date : May 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00479687

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

Responsible Party: Bioventus LLC Identifier: NCT00479687     History of Changes
Other Study ID Numbers: SHO-0106
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: July 2013

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