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

Phase 3

Completed

• Conditions: Osteoarthritis; Musculoskeletal Diseases

• Registration Number: NCT00131300
• Lead Sponsor: Genzyme, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-08-17
• Study First Submitted QC: 2005-08-17
• Study First Posted: 2005-08-18
• Study Completion: 2006-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain relief

Trial Locations

Locations (6)

Hopital Ambroise Pare; 🇫🇷 Boulogne-Billancourt, France

Clinique Saint Anne Lumiere; 🇫🇷 Lyon, France

Centre de Medecine et Traumatologie du Sport Clinique du Sport; 🇫🇷 Merignac, France

CHRU Hopital Trousseau; 🇫🇷 Tours, France

August-Viktoria-Klinik; 🇩🇪 Bad Oeynhausen, Germany

Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin; 🇩🇪 Halle/Saale, Germany