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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00131768 |
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 |
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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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | David Perkins | Genzyme |
Study ID Numbers: | SYNV-003-02 |
Study First Received: | August 17, 2005 |
Last Updated: | November 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00131768 History of Changes |
Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
osteoarthritis of the ankle musculoskeletal |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |