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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00131326
First received: August 17, 2005
Last updated: August 3, 2009
Last verified: February 2007
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Hip
Musculoskeletal Diseases
Device: Synvisc (hylan G-F 20)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • Pain relief

Study Start Date: November 2003
Estimated Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131326

  Hide Study Locations
Locations
United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
John Higginbotham, MD Sports Medicine
Huntsville, Alabama, United States, 35802
United States, Arizona
Affiliated Orthopedic Specialists
Scottsdale, Arizona, United States, 85260
United States, Arkansas
Arkansas Orthopaedic Specialists
Little Rock, Arkansas, United States, 72205
United States, California
Cedars-Sinai Orthopedic Center
Los Angeles, California, United States, 90048
Jackson Arthritis Center
Oakland, California, United States, 94609
Orthopedic Medical Group
San Diego, California, United States, 92123
United States, Florida
Orthopedic Specialists of Tamp Bay, P.A.
Clearwater, Florida, United States, 33756
Orthopedic Institute at Mercy Hospital
Miami, Florida, United States, 33133
United States, Georgia
Hughston Sports Medicine Foundation
Columbus, Georgia, United States, 31909
United States, Idaho
Idaho Arthritis & Osteoporosis Center
Meridian, Idaho, United States, 83642
United States, Illinois
Northwestern Orthopaedic Institute
Chicago, Illinois, United States, 60611
Illinois Bone and Joint Institute, Ltd.
Morton Grove, Illinois, United States, 60053
United States, Iowa
David S. Tearse, MD (Private Practice)
Cedar Rapids, Iowa, United States, 52403
United States, Kansas
Kansas City Orthopedic Institute
Leawood, Kansas, United States, 66211
United States, Kentucky
Bluegrass Orthopaedics
Lexington, Kentucky, United States, 40509
United States, Louisiana
Orthopedic Specialists of Louisiana
Shreveport, Louisiana, United States, 71101
United States, Maryland
Maryland General Hospital
Baltimore, Maryland, United States, 21201
United States, Michigan
Family Orthopedic Associates
Flint, Michigan, United States, 48507
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
UMDNJ-RWJ University Orthopedic Group
New Brunswick, New Jersey, United States, 08901
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Oklahoma
Health Research Institute
Oklahoma City, Oklahoma, United States, 73109
United States, Oregon
Orthopedic Center for Joint Replacement & Sports Medicine
Grants Pass, Oregon, United States, 97527
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Lancaster Orthopedic Group
Lancaster, Pennsylvania, United States, 17601
Allegheny Orthopedic Associates
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Conway Medical Center
Conway, South Carolina, United States, 29526
United States, Tennessee
Chattanooga Center for Sports
Chattanooga, Tennessee, United States, 37404
United States, Texas
Gurdev Gill, MD (Private Practice)
Lubbock, Texas, United States, 79410
United States, Virginia
Carilion Bone and Joint Center, Vinton Orthopedic Surgery
Vinton, Virginia, United States, 24179
United States, Washington
Arthritis Northwest
Seattle, Washington, United States, 98166-2967
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00131326     History of Changes
Other Study ID Numbers: SYNV-004-02
Study First Received: August 17, 2005
Last Updated: August 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
osteoarthritis of the hip
Musculoskeletal Diseases

Additional relevant MeSH terms:
Musculoskeletal Diseases
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014