SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

Osteoarthritis of the Shoulder Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo Controlled Trial of SUPARTZ (Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479687
• Other study ID #: SHO-0106
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: October 2009

Study information

• Verified date: April 2021
• Source: Bioventus LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Phase 3 Study: Multi-center, randomized, double blinded, two phase study to determine the safety and efficacy of 3 injections of SUPARTZ for Osteoarthritis of the Shoulder

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Shoulder

Intervention

Device:
• SUPARTZ®
Three Supartz injections over 2 weeks into the glenohumeral joint space.
• Phosphate Buffered Saline
Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bioventus LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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