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

NCT ID: NCT00139295

Last Updated: 2014-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-09-30

Brief Summary

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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

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Hylastan

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Genzyme Corporation

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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Capstone Clinical Trials, Inc

Birmingham, Alabama, United States

Site Status

Hope Research Institute, LLC

Phoenix, Arizona, United States

Site Status

Tucson Orthopedic Institute, PC

Tucson, Arizona, United States

Site Status

Orthopaedic Specialties of Tampa Bay

Clearwater, Florida, United States

Site Status

Northwestern Center for Clinical Research

Chicago, Illinois, United States

Site Status

Midwest Orthopedics at Rush University Medical Center

Chicago, Illinois, United States

Site Status

Rockford Health Physicians

Rockford, Illinois, United States

Site Status

Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research

Lexington, Kentucky, United States

Site Status

Orthopedic Specialists of Louisiana

Shreveport, Louisiana, United States

Site Status

Arthritis & Osteoporosis Center of Maryland

Frederick, Maryland, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Orthopedic Center for Joint Replacement and Sports

Grants Pass, Oregon, United States

Site Status

Coastal Orthopedic Associates

Conway, South Carolina, United States

Site Status

Unlimited Research

San Antonio, Texas, United States

Site Status

Arthritis Northwest

Seattle, Washington, United States

Site Status

Sir William Osler Health Institute

Hamilton, Ontario, Canada

Site Status

Clinique du Sport

Mérignac, , France

Site Status

Centre Hospitalier Lyon-Sud, Service de Rhumatologie

Pierre-Bénite, , France

Site Status

CHU Hôpital Trousseau Service de Rhumatologie

Tours, , France

Site Status

St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis

Heidelberg, , Germany

Site Status

Orthopaedische Gemeinschaftspraxis

Weyhe-Kirchweyhe, , Germany

Site Status

Southampton General Hospital, MRC Environmental Epidemiology Unit

Southampton, Hampshire, United Kingdom

Site Status

Maidstone General Hospital & Tunbridge Wells NHS Trust

Maidstone, Kent, United Kingdom

Site Status

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

Leytonstone, London, United Kingdom

Site Status

Countries

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United States Canada France Germany United Kingdom

Other Identifiers

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AVS00103

Identifier Type: -

Identifier Source: org_study_id

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