SYNV00704: A Study of the Safety and Efficacy of Synvisc in Patients with Symptomatic Osteoarthritis of the Knee

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00131352

Purpose

This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic knee osteoarthritis (OA). Patients will be given Synvisc, with a possible repeat treatment with Synvisc after the week 26 visit.

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details:

Primary Outcomes: Pain relief

Study start: May 2005; Study completion: August 2006

Eligibility

Ages Eligible for Study: 40 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Patients with symptomatic OA pain of the knee

Exclusion Criteria:

Patients with current or prior conditions or treatment that would impede measurement of efficacy or safety

Location Information

Belgium
CHU Liege, LIEGE, 4000, Belgium
Hopital Erasme, BRUXELLES, 1070, Belgium
Universitair Ziekenhuis Gastuisberg Leuven, Leuven, 3000, Belgium
Universitair Ziekenhuis Gent, Gent, 9000, Belgium

Czech Republic
Institute of Rheumatology, PRAGUE 2, 12850, Czech Republic
Faculty Thomayer Hospital, PRAGUE 4, 14059, Czech Republic
Faculty Hospital Motol, Prague, 15006, Czech Republic
Faculty Hospital Bohunice, Brno, 62500, Czech Republic

France
Hopital Rangueil, Toulouse Cedex 9, 31059, France
Hopital Henri Mondor, Creteil cedex, 94010, France
Hopital de la Conception, Marseille, 13005, France
CHU Hopital Trousseau, Tours Cedex, 37044, France
CHU Dupuytren, Limoges Cedex, 87042, France

Germany
Johanna-Etienne Krankenhaus, Neuss, 41462, German

Netherlands
AMC/UVA, Amsterdam, 1100, Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, 6202 AZ, Netherlands

United Kingdom
Kings College Hospital, London, SE5 9RJ, United Kingdom
University Hospital of Wales, Cardiff, CF14 4XW, United Kingdom
Freeman Hospital, Newcastle upon Tyne, NE7 7DN, United Kingdom
Nuffield Orthopaedic Centre, Oxford, OX3 7LD, United Kingdom
Trafford General Hospital, Manchester, M41 5SL, United Kingdom

More Information

Study ID Numbers: SYNV00704
ClinicalTrials.gov Identifier: NCT00131352
Health Authority: France: Afssaps - French Health Products Safety Agency