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Completed

NCT Number: NCT00479687

SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

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.

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Key information

Conditions

Osteoarthritis of the Shoulder Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SUPARTZ®

Device

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

Phosphate Buffered Saline

Device

Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.

Other names: Saline

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bioventus LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 28, 2007
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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