SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioventus LLC
ClinicalTrials.gov Identifier:
NCT00479687
First received: May 24, 2007
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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
Glenohumeral Osteoarthritis of the Shoulder
Device: SUPARTZ
Device: Saline
Phase 3

Study Type: Interventional
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

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 ] [ Designated as safety issue: Yes ]

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

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: 1
Supartz
Device: SUPARTZ
Supartz injection into the glenohumeral joint space.
Placebo Comparator: 2
Saline
Device: 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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00479687

  Show 23 Study Locations
Sponsors and Collaborators
Bioventus LLC
  More Information

No publications provided

Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT00479687     History of Changes
Other Study ID Numbers: SHO-0106
Study First Received: May 24, 2007
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bioventus LLC:
Osteoarthritis
Shoulder

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 27, 2014