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

This study is currently recruiting patients.
Verified by Genzyme August 2005

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 OA. Patients will be given Synvisc, with a possible repeat treatment with Synvisc after week 26 visit.
Condition Intervention Phase
Osteoarthritis of the knee
Musculoskeletal
 Device: Synvisc (hylan G-F 20)
Phase III

MedlinePlus related topics:  Osteoarthritis

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;  Expected completion: December 2006
Last follow-up: August 2006;  Data entry closure: September 2006

Eligibility

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

Inclusion Criteria:

Exclusion Criteria:

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00131352

Medical Information      617-252-7832    medinfo@genzyme.com

Belgium
      CHU Liege, LIEGE,  4000,  Belgium; Recruiting

      Hopital Erasme, BRUXELLES,  1070,  Belgium; Recruiting

      Universitair Ziekenhuis Gastuisberg Leuven, Leuven,  3000,  Belgium; Recruiting

      Universitair Ziekenhuis Gent, Gent,  9000,  Belgium; Recruiting

Czech Republic
      Institute of Rheumatology, PRAGUE 2,  12850,  Czech Republic; Recruiting

      Faculty Thomayer Hospital, PRAGUE 4,  14059,  Czech Republic; Recruiting

      Faculty Hospital Motol, Prague,  15006,  Czech Republic; Recruiting

      Faculty Hospital Bohunice, Brno,  62500,  Czech Republic; Recruiting

France
      Hopital Rangueil, Toulouse Cedex 9,  31059,  France; Recruiting

      Hopital Henri Mondor, Creteil cedex,  94010,  France; Recruiting

      Hopital de la Conception, Marseille,  13005,  France; Recruiting

      CHU Hopital Trousseau, Tours Cedex,  37044,  France; Recruiting

      CHU Dupuytren, Limoges Cedex,  87042,  France; Recruiting

Germany
      Johanna-Etienne Krankenhaus, Neuss,  41462,  Germany; Recruiting

Netherlands
      AMC/UVA, Amsterdam,  1100,  Netherlands; Recruiting

      Academisch Ziekenhuis Maastricht, Maastricht,  6202 AZ,  Netherlands; Recruiting

United Kingdom
      Kings College Hospital, London,  SE5 9RJ,  United Kingdom; Recruiting

      University Hospital of Wales, Cardiff,  CF14 4XW,  United Kingdom; Recruiting

      Freeman Hospital, Newcastle upon Tyne,  NE7 7DN,  United Kingdom; Recruiting

      Nuffield Orthopaedic Centre, Oxford,  OX3 7LD,  United Kingdom; Recruiting

      Trafford General Hospital, Manchester,  M41 5SL,  United Kingdom; Recruiting

Study chairs or principal investigators

David Perkins,  Study Director,  Genzyme   

More Information

Study ID Numbers:  SYNV00704
Last Updated:  August 17, 2005
Record first received:  August 17, 2005
ClinicalTrials.gov Identifier:  NCT00131352
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23

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