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
ClinicalTrials.gov Identifier: NCT00131300

Purpose

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
Musculoskeletal
 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

Eligibility

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

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


France
      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

Germany
      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
ClinicalTrials.gov Identifier:  NCT00131300
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23

Resources




Common Treatments

[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Follow Us