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SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

NCT00479687 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-04-27

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Bioventus LLC

    lead INDUSTRY

Principal Investigators

  • Scott Sledge, MD · Northeast Orthopedics - Unlimited Research

  • Charles Birbara, MD · Clinical Pharmacology Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-10-31
Completion
2009-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479687 on ClinicalTrials.gov