SYNV-002-01: A Study of the Safety and Efficacy of Synvisc in Patients with Symptomatic Shoulder Osteoarthritis

This study has been completed.

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 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	Intervention	Phase
Osteoarthritis Musculoskeletal Diseases	Device: Synvisc (hylan G-F 20)	Phase III

Study Type: Interventional

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

Official Title: A Long-Term Continuation Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602

Further Study Details:

Primary Outcomes: Pain relief

Study start: April 2004; February 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

More Information

Study ID Numbers: SYNV-002-01
ClinicalTrials.gov Identifier: NCT00131300
Health Authority: France: Afssaps - French Health Products Safety Agency