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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00131326
Other study ID # SYNV-004-02
Secondary ID
Status Completed
Phase Phase 3
First received August 17, 2005
Last updated July 27, 2017
Start date November 2003
Est. completion date April 2006

Study information

Verified date July 2017
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 35 Years and older
Eligibility 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

Study Design


Intervention

Device:
Synvisc (hylan G-F 20)


Locations

Country Name City State
United States Maryland General Hospital Baltimore Maryland
United States Alabama Clinical Therapeutics Birmingham Alabama
United States David S. Tearse, MD (Private Practice) Cedar Rapids Iowa
United States Chattanooga Center for Sports Chattanooga Tennessee
United States Northwestern Orthopaedic Institute Chicago Illinois
United States Orthopedic Specialists of Tamp Bay, P.A. Clearwater Florida
United States Hughston Sports Medicine Foundation Columbus Georgia
United States Conway Medical Center Conway South Carolina
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States Family Orthopedic Associates Flint Michigan
United States Orthopedic Center for Joint Replacement & Sports Medicine Grants Pass Oregon
United States John Higginbotham, MD Sports Medicine Huntsville Alabama
United States Lancaster Orthopedic Group Lancaster Pennsylvania
United States Kansas City Orthopedic Institute Leawood Kansas
United States Bluegrass Orthopaedics Lexington Kentucky
United States Arkansas Orthopaedic Specialists Little Rock Arkansas
United States Cedars-Sinai Orthopedic Center Los Angeles California
United States Gurdev Gill, MD (Private Practice) Lubbock Texas
United States Idaho Arthritis & Osteoporosis Center Meridian Idaho
United States Orthopedic Institute at Mercy Hospital Miami Florida
United States Illinois Bone and Joint Institute, Ltd. Morton Grove Illinois
United States UMDNJ-RWJ University Orthopedic Group New Brunswick New Jersey
United States Hospital for Special Surgery New York New York
United States Jackson Arthritis Center Oakland California
United States Health Research Institute Oklahoma City Oklahoma
United States Allegheny Orthopedic Associates Pittsburgh Pennsylvania
United States Washington University School of Medicine Saint Louis Missouri
United States Orthopedic Medical Group San Diego California
United States Affiliated Orthopedic Specialists Scottsdale Arizona
United States Arthritis Northwest Seattle Washington
United States Orthopedic Specialists of Louisiana Shreveport Louisiana
United States Carilion Bone and Joint Center, Vinton Orthopedic Surgery Vinton Virginia

Sponsors (1)

Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain relief
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