SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

NCT ID: NCT00479687

Last Updated: 2021-04-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-10-31

Brief Summary

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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

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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

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Osteoarthritis of the Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Supartz

SUPARTZ® 3 injections over 2 weeks

Group Type ACTIVE_COMPARATOR

SUPARTZ®

Intervention Type DEVICE

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

Phosphate Buffered Saline

Phosphate Buffered Saline 3 injections over 2 weeks

Group Type PLACEBO_COMPARATOR

Phosphate Buffered Saline

Intervention Type DEVICE

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

Interventions

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SUPARTZ®

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

Intervention Type DEVICE

Phosphate Buffered Saline

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

Intervention Type DEVICE

Other Intervention Names

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Saline

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bioventus LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Sledge, MD

Role: PRINCIPAL_INVESTIGATOR

Northeast Orthopedics - Unlimited Research

Charles Birbara, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology Study Group

Other Identifiers

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SHO-0106

Identifier Type: -

Identifier Source: org_study_id

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