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.

SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

Osteoarthritis of the Shoulder

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

SUPARTZ®

Phosphate Buffered Saline

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

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

Phosphate Buffered Saline 3 injections over 2 weeks

This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.

SUPARTZ® 3 injections over 2 weeks

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

Supartz (Double Blind)

Phosphate Buffered Saline 3 injections over 2 weeks

Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.

Phosphate Buffered Saline (Double Blind)

Supartz (Open Label)

Ph1: Supartz (Double Blind)

Ph1: Phosphate Buffered Saline (Double Blind)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Double Blind = Intention-to-treat (ITT): all subjects randomized Open Label = Retreatment Subjects, All ITT subjects

Regulatory and Clinical Affairs

Glenohumeral Osteoarthritis (GH-OA) Intention-to-Treat (ITT) population includes all randomized subjects who had no clinical diagnosis of concomitant pathologies in the trial shoulder

SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?