SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

April 5, 2021 updated by: Bioventus LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Supartz
SUPARTZ® 3 injections over 2 weeks
Device: SUPARTZ®
Three Supartz injections over 2 weeks into the glenohumeral joint space.
Placebo Comparator: Phosphate Buffered Saline
Phosphate Buffered Saline 3 injections over 2 weeks
Device: Phosphate Buffered Saline
Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS: 0-100) for Pain on Movement
Time Frame: Ph1: weeks 7 - 26

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioventus LLC

Investigators

  • Principal Investigator: Scott Sledge, MD, Northeast Orthopedics - Unlimited Research
  • Principal Investigator: Charles Birbara, MD, Clinical Pharmacology Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 24, 2007

First Submitted That Met QC Criteria

May 24, 2007

First Posted (Estimate)

May 28, 2007

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHO-0106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis of the Shoulder

Clinical Trials on SUPARTZ®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe