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

This study has been completed.

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

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 III

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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
Johanna Etienne Krankenhaus
Neuss, Germany, D-41462
Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie
Frankfurt, Germany, D-60528
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:

David Perkins

Genzyme

More Information

Study ID Numbers:	SYNV-003-02
Study First Received:	August 17, 2005
Last Updated:	November 22, 2006
ClinicalTrials.gov Identifier:	NCT00131768
Health Authority:	Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Genzyme:

osteoarthritis of the ankle
musculoskeletal

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009