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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:
ClinicalTrials.gov Identifier:
NCT00131768
First Posted: August 19, 2005
Last Update Posted: March 18, 2015
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.
Information provided by:
Sanofi
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Pain relief

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00131768     History of Changes
Other Study ID Numbers: SYNV-003-02
First Submitted: August 17, 2005
First Posted: August 19, 2005
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Sanofi:
osteoarthritis of the ankle
musculoskeletal

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hylan
Viscosupplements
Protective Agents
Physiological Effects of Drugs