Comparison of Hylastan to Methylprednisolone Acetate in P... | NCT00139295 | Trialant

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Comparison of Hylastan to Methylprednisolone Acetate in P... | NCT00139295 | Trialant

Studies
Comparison of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

NCT00139295

Sponsor

Genzyme, a Sanofi Company

Status

Completed

Last Update Posted

Feb 5, 2014Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Osteoarthritis, Knee

Interventions

Hylastan

Countries

United States
Canada
France
Germany
United Kingdom

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

NCT00139295

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

AVS00103

Secondary IDs

Not provided

Brief Title

Comparison of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

Official Title

Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

Acronym

Not provided

Organization

SanofiINDUSTRY

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2004

Primary Completion Date

Not provided

Completion Date

Sep 2007Actual

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 29, 2005

First Posted Date

Aug 31, 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

Feb 4, 2014

Last Update Posted Date

Feb 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Genzyme, a Sanofi CompanyINDUSTRY

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.

Detailed Description

Not provided

Conditions Module

Conditions

Osteoarthritis, Knee

Keywords

musculoskeletal
osteoarthritis of the knee

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

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hylastan	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain relief

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with OA of the knee
Have tried but not been sufficiently helped by conservative treatment, such as weight reduction and pain medications

Exclusion Criteria:

Prior or concomitant treatments that would impede measurement of safety and efficacy

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 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
Capstone Clinical Trials, Inc		Birmingham	Alabama	35209	United States
Hope Research Institute, LLC

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

Double

Masking Description

Not provided

Who Masked

Not provided

Phoenix

Arizona

85050

United States

Tucson Orthopedic Institute, PC

Tucson

Arizona

85712

United States

Orthopaedic Specialties of Tampa Bay

Clearwater

Florida

33756

United States

Northwestern Center for Clinical Research

Chicago

Illinois

60611

United States

Midwest Orthopedics at Rush University Medical Center

Chicago

Illinois

60612

United States

Rockford Health Physicians

Rockford

Illinois

61103

United States

Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research

Lexington

Kentucky

40509

United States

Orthopedic Specialists of Louisiana

Shreveport

Louisiana

71101

United States

Arthritis & Osteoporosis Center of Maryland

Frederick

Maryland

21702

United States

Clinical Pharmacology Study Group

Worcester

Massachusetts

01610

United States

Orthopedic Center for Joint Replacement and Sports

Grants Pass

Oregon

97527

United States

Coastal Orthopedic Associates

Conway

South Carolina

29526

United States

Unlimited Research

San Antonio

Texas

78217

United States

Arthritis Northwest

Seattle

Washington

98166

United States

Sir William Osler Health Institute

Hamilton

Ontario

L9C 7N4

Canada

Clinique du Sport

Mérignac

33700

France

Centre Hospitalier Lyon-Sud, Service de Rhumatologie

Pierre-Bénite

69495

France

CHU Hôpital Trousseau Service de Rhumatologie

Tours

37044

France

St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis

Heidelberg

69121

Germany

Orthopaedische Gemeinschaftspraxis

Weyhe-Kirchweyhe

28844

Germany

Southampton General Hospital, MRC Environmental Epidemiology Unit

Southampton

Hampshire

SO16 6YD

United Kingdom

Maidstone General Hospital & Tunbridge Wells NHS Trust

Maidstone

Kent

ME16 9QQ

United Kingdom

Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department

Leytonstone

London

E11 1NR

United Kingdom

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided