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

This study has been completed.
Sponsor:
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00131768
First received: August 17, 2005
Last updated: August 3, 2009
Last verified: November 2006
History of Changes
  Purpose

This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic ankle osteoarthritis (OA). Patients will be given 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
 Device: Synvisc (hylan G-F 20)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Pain relief

Study Start Date: November 2003
Estimated Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131768

Locations
Germany
Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie
Frankfurt, Germany, D-60528
Johanna Etienne Krankenhaus
Neuss, Germany, D-41462
Italy
Instituti Ortopedici Rizzoli
Bologna, Italy, 40136
Ospedale Santa Chiara, Clinica Ortopedica, Universita di Pisa
Pisa, Italy, 56126
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1100 DD
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor Genzyme
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00131768     History of Changes
Other Study ID Numbers: SYNV-003-02
Study First Received: August 17, 2005
Last Updated: August 3, 2009
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Genzyme:
osteoarthritis of the ankle
musculoskeletal

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013