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

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ClinicalTrials.gov Identifier: NCT00131300
Recruitment Status : Completed
First Posted : August 18, 2005
Last Update Posted : March 18, 2015
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Musculoskeletal Diseases Device: Synvisc (hylan G-F 20) Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2004
Estimated Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Primary Outcome Measures :
  1. Pain relief

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131300

Hopital Ambroise Pare
Boulogne-Billancourt, France, 92100
Clinique Saint Anne Lumiere
Lyon, France, 69003
Centre de Medecine et Traumatologie du Sport Clinique du Sport
Merignac, France, 33700
CHRU Hopital Trousseau
Tours, France, 37044
Bad Oeynhausen, Germany, 32545
Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin
Halle/Saale, Germany, 06097
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00131300     History of Changes
Other Study ID Numbers: SYNV-002-01
First Posted: August 18, 2005    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Sanofi:
Osteoarthritis of the shoulder

Additional relevant MeSH terms:
Musculoskeletal Diseases
Joint Diseases
Rheumatic Diseases
Protective Agents
Physiological Effects of Drugs