NCT00479687

SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Bioventus LLC · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Osteoarthritis of the Shoulder

Interventions

Type	Name	Description
DEVICE	SUPARTZ®	Three Supartz injections over 2 weeks into the glenohumeral joint space.
DEVICE	Phosphate Buffered Saline	Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-05-28
• Last updated: 2021-04-27
• Results posted: 2021-04-02