A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis

NCT ID: NCT00131300

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-02-28

Brief Summary

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This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period.

Detailed Description

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Conditions

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Osteoarthritis Musculoskeletal Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Synvisc (hylan G-F 20)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with symptomatic OA pain of shoulder (gleno-humeral)

Exclusion Criteria

* Patients with current or prior conditions or treatment that would impede measurement of efficacy or safety
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Genzyme Corporation

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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Hopital Ambroise Pare

Boulogne-Billancourt, , France

Site Status

Clinique Saint Anne Lumiere

Lyon, , France

Site Status

Centre de Medecine et Traumatologie du Sport Clinique du Sport

Mérignac, , France

Site Status

CHRU Hopital Trousseau

Tours, , France

Site Status

August-Viktoria-Klinik

Bad Oeynhausen, , Germany

Site Status

Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin

Halle, , Germany

Site Status

Countries

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France Germany

Other Identifiers

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SYNV-002-01

Identifier Type: -

Identifier Source: org_study_id

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