A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip

NCT ID: NCT00131326

Last Updated: 2017-07-31

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

2003-11-30

Study Completion Date

2006-04-30

Brief Summary

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This is a clinical study to investigate the safety and efficacy of Synvisc and Depo-Medrol in treating patients with osteoarthritis (OA) of the hip.

Detailed Description

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Conditions

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Osteoarthritis, Hip Musculoskeletal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Synvisc (hylan G-F 20)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with symptomatic osteoarthritis pain of hip

Exclusion Criteria

* Patients with current or prior conditions or treatment that would impede measurement of efficacy and safety
Minimum Eligible Age

35 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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Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Site Status

John Higginbotham, MD Sports Medicine

Huntsville, Alabama, United States

Site Status

Affiliated Orthopedic Specialists

Scottsdale, Arizona, United States

Site Status

Arkansas Orthopaedic Specialists

Little Rock, Arkansas, United States

Site Status

Cedars-Sinai Orthopedic Center

Los Angeles, California, United States

Site Status

Jackson Arthritis Center

Oakland, California, United States

Site Status

Orthopedic Medical Group

San Diego, California, United States

Site Status

Orthopedic Specialists of Tamp Bay, P.A.

Clearwater, Florida, United States

Site Status

Orthopedic Institute at Mercy Hospital

Miami, Florida, United States

Site Status

Hughston Sports Medicine Foundation

Columbus, Georgia, United States

Site Status

Idaho Arthritis & Osteoporosis Center

Meridian, Idaho, United States

Site Status

Northwestern Orthopaedic Institute

Chicago, Illinois, United States

Site Status

Illinois Bone and Joint Institute, Ltd.

Morton Grove, Illinois, United States

Site Status

David S. Tearse, MD (Private Practice)

Cedar Rapids, Iowa, United States

Site Status

Kansas City Orthopedic Institute

Leawood, Kansas, United States

Site Status

Bluegrass Orthopaedics

Lexington, Kentucky, United States

Site Status

Orthopedic Specialists of Louisiana

Shreveport, Louisiana, United States

Site Status

Maryland General Hospital

Baltimore, Maryland, United States

Site Status

Family Orthopedic Associates

Flint, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

UMDNJ-RWJ University Orthopedic Group

New Brunswick, New Jersey, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

Health Research Institute

Oklahoma City, Oklahoma, United States

Site Status

Orthopedic Center for Joint Replacement & Sports Medicine

Grants Pass, Oregon, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Lancaster Orthopedic Group

Lancaster, Pennsylvania, United States

Site Status

Allegheny Orthopedic Associates

Pittsburgh, Pennsylvania, United States

Site Status

Conway Medical Center

Conway, South Carolina, United States

Site Status

Chattanooga Center for Sports

Chattanooga, Tennessee, United States

Site Status

Gurdev Gill, MD (Private Practice)

Lubbock, Texas, United States

Site Status

Carilion Bone and Joint Center, Vinton Orthopedic Surgery

Vinton, Virginia, United States

Site Status

Arthritis Northwest

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Spitzer AI, Bockow BI, Brander VA, Yates JW, MacCarter DK, Gudger GK, Haller S, Lake SL, Magilavy DB. Hylan G-F 20 improves hip osteoarthritis: a prospective, randomized study. Phys Sportsmed. 2010 Jun;38(2):35-47. doi: 10.3810/psm.2010.06.1781.

Reference Type BACKGROUND
PMID: 20631462 (View on PubMed)

Other Identifiers

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SYNV-004-02

Identifier Type: -

Identifier Source: org_study_id

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