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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00131768
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : March 18, 2015
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Device: Synvisc (hylan G-F 20) Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2003
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  1. Pain relief

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00131768

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

Responsible Party: Medical Monitor, Genzyme Corporation Identifier: NCT00131768     History of Changes
Other Study ID Numbers: SYNV-003-02
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Sanofi:
osteoarthritis of the ankle

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Protective Agents
Physiological Effects of Drugs