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

March 17, 2015 updated by: Genzyme, a Sanofi Company
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, D-60528
        • Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie
      • Neuss, Germany, D-41462
        • Johanna Etienne Krankenhaus
  • Italy
      • Bologna, Italy, 40136
        • Instituti Ortopedici Rizzoli
      • Pisa, Italy, 56126
        • Ospedale Santa Chiara, Clinica Ortopedica, Universita di Pisa
  • Netherlands
      • Amsterdam, Netherlands, 1100 DD
        • Academisch Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain relief

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

August 17, 2005

First Submitted That Met QC Criteria

August 17, 2005

First Posted (Estimate)

August 19, 2005

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYNV-003-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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