A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Ankle Osteoarthritis
Phase 3
Completed
- Conditions
- Osteoarthritis
- Registration Number
- NCT00131768
- Lead Sponsor
- Genzyme, a Sanofi Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pain relief
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Instituti Ortopedici Rizzoli
🇮🇹Bologna, Italy
Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie
🇩🇪Frankfurt, Germany
Ospedale Santa Chiara, Clinica Ortopedica, Universita di Pisa
🇮🇹Pisa, Italy
Johanna Etienne Krankenhaus
🇩🇪Neuss, Germany
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands