A Study of the Safety and Efficacy of Synvisc in Patients... | NCT00131768

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

NCT00131768

Sponsor

Genzyme, a Sanofi Company

Status

Completed

Last Update Posted

Mar 18, 2015Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Osteoarthritis

Interventions

Synvisc (hylan G-F 20)

Countries

Germany
Italy
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Aug 17, 2005

First Submission Date that Met QC Criteria

Aug 17, 2005

First Posted Date

Aug 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2015

Last Update Posted Date

Mar 18, 2015Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Synvisc (hylan G-F 20)	Device

Measure	Description	Time Frame
Pain relief

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sportmedizinisches Institut Frankfurt am Main e.V. Orthopadie		Frankfurt		D-60528	Germany
Johanna Etienne Krankenhaus

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided