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

This study is no longer recruiting patients.

Sponsored by: Genzyme
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00131768

Purpose

This clinical study is to evaluate the safety and effficacy of Synvisc in patients with symptomatic ankle OA. Patients will be gicen Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the initial 3 months follow up period.
Condition Intervention Phase
osteoarthritis of the ankle
musculoskeletal
 Device: Synvisc (hylan G-F 20)
Phase III

MedlinePlus related topics:  Osteoarthritis

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: November 2003;  Study completion: September 2006
Last follow-up: February 2006;  Data entry closure: March 2006

Eligibility

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

Inclusion Criteria:

  • patients with symptomatic OA pain of ankle (talo-crural)

Exclusion Criteria:

  • patients with current or prior conditions or treatments that would impede measurements of efficacy or safety

Location Information


Germany
      Johanna Etienne Krankenhaus, Neuss,  D-41462,  Germany

      Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie, Frankfurt,  D-60528,  Germany

Italy
      Instituti Ortopedici Rizzoli, Bologna,  40136,  Italy

      Ospedale Santa Chiara, Clinica Ortopedica, Universita di Pisa, Pisa,  56126,  Italy

Netherlands
      Academisch Medisch Centrum, Amsterdam,  1100 DD,  Netherlands

Study chairs or principal investigators

David Perkins,  Study Director,  Genzyme   

More Information

Study ID Numbers:  SYNV-003-02
Last Updated:  August 18, 2005
Record first received:  August 17, 2005
ClinicalTrials.gov Identifier:  NCT00131768
Health Authority: Netherlands: Medicines Evaluation Board (MEB)
ClinicalTrials.gov processed this record on 2005-09-13

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