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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 17, 2005

Last Updated Date

November 22, 2006

Start Date ^†

November 2003

Current Primary Outcome Measures ^†

Pain relief

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00131768 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Osteoarthritis

Intervention ^†

Device: Synvisc (hylan G-F 20)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

February 2006

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany, Italy, Netherlands

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00131768

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Genzyme

Collaborators ^††

Investigators ^†

Study Director:

David Perkins

Genzyme

Information Provided By

Genzyme

Verification Date

November 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.