SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

NCT00479687 | Completed Results

• 1 other identifier: SHO-0106
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis of the Shoulder

Keywords

Osteoarthritis; Shoulder; Hyaluronic Acid (HA)

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS: 0-100) for Pain on Movement

  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

  Ph1: weeks 7 - 26

Study Arms (2)

Supartz

ACTIVE COMPARATOR

SUPARTZ® 3 injections over 2 weeks

Device: SUPARTZ®

Phosphate Buffered Saline

PLACEBO COMPARATOR

Phosphate Buffered Saline 3 injections over 2 weeks

Device: Phosphate Buffered Saline

Interventions

SUPARTZ® DEVICE

Three Supartz injections over 2 weeks into the glenohumeral joint space.

Supartz

Phosphate Buffered Saline DEVICE

Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.

Also known as: Saline

Phosphate Buffered Saline

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Full thickness rotator cuff tear or rotator cuff tendinopathy
• Frozen shoulder
• Female who is pregnant or lactating

Sponsors & Collaborators

• Bioventus LLC: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Regulatory and Clinical Affairs
• Organization: Bioventus LLC

CT.gov@bioventusglobal.com

18003964325

Study Officials

• Scott Sledge, MD

  Northeast Orthopedics - Unlimited Research

  PRINCIPAL INVESTIGATOR

• Charles Birbara, MD

  Clinical Pharmacology Study Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 28, 2007
• Study Start: May 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 27, 2021
• Results First Posted: April 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share