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NCT00131768 Clinical Trial

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

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00131768
Other study ID # SYNV-003-02
Secondary ID
Status Completed
Phase Phase 3
First received August 17, 2005
Last updated March 17, 2015
Start date November 2003
Est. completion date February 2006

Study information
Verified date March 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medicines Evaluation Board (MEB)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Synvisc (hylan G-F 20)

Locations
Country Name City State
Germany Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie Frankfurt
Germany Johanna Etienne Krankenhaus Neuss
Italy Instituti Ortopedici Rizzoli Bologna
Italy Ospedale Santa Chiara, Clinica Ortopedica, Universita di Pisa Pisa
Netherlands Academisch Medisch Centrum Amsterdam

Sponsors (1)
Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain relief
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