Clinical Trial: A Study of the Safety and Efficacy of Synvisc in Patients with Symptomatic Shoulder Osteoarthritis.

This study is no longer recruiting patients.

Sponsored by: Genzyme
Information provided by: Genzyme Identifier: NCT00131300


This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder OA. Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 months follow up period.
Condition Intervention Phase
Osteoarthritis of the shoulder
 Device: Synvisc (hylan G-F 20)
Phase III

MedlinePlus related topics:  Osteoarthritis;   Pain

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: Pain relief

Study start: April 2004;  Study completion: September 2006
Last follow-up: February 2006;  Data entry closure: April 2006


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Location Information

      Clinique Saint Anne Lumiere, Lyon,  69003,  France

      CHRU Hopital Trousseau, Tours,  37044,  France

      Hopital Ambroise Pare, Boulogne-Billancourt,  92100,  France

      Centre de Medecine et Traumatologie du Sport Clinique du Sport, Merignac,  33700,  France

      August-Viktoria-Klinik, Bad Oeynhausen,  32545,  Germany

      Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin, Halle/Saale,  06097,  Germany

Study chairs or principal investigators

David Perkins,  Study Director,  Genzyme   

More Information

Study ID Numbers:  SYNV-002-01
Last Updated:  August 17, 2005
Record first received:  August 17, 2005 Identifier:  NCT00131300
Health Authority: France: Afssaps - French Health Products Safety Agency processed this record on 2005-08-23


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