SYNV-003-02: 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

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: February 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

More Information

Study ID Numbers: SYNV-003-02
ClinicalTrials.gov Identifier: NCT00131768
Health Authority: Netherlands: Medicines Evaluation Board (MEB)