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

NCT00139295 | Completed Phase 3

• 1 other identifier: AVS00103
• Study Type: interventional
• Target: N/A
• Locations: 5 countries
• Sites: 24

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.

Conditions

Osteoarthritis, Knee

Keywords

musculoskeletal; osteoarthritis of the knee

Outcome Measures

Primary Outcomes (1)

• pain relief

Interventions

Hylastan DEVICE

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (24)

Capstone Clinical Trials, Inc

Birmingham, Alabama, 35209, United States

Location

Hope Research Institute, LLC

Phoenix, Arizona, 85050, United States

Location

Tucson Orthopedic Institute, PC

Tucson, Arizona, 85712, United States

Location

Orthopaedic Specialties of Tampa Bay

Clearwater, Florida, 33756, United States

Location

Northwestern Center for Clinical Research

Chicago, Illinois, 60611, United States

Location

Midwest Orthopedics at Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Rockford Health Physicians

Rockford, Illinois, 61103, United States

Location

Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research

Lexington, Kentucky, 40509, United States

Location

Orthopedic Specialists of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Arthritis & Osteoporosis Center of Maryland

Frederick, Maryland, 21702, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01610, United States

Location

Orthopedic Center for Joint Replacement and Sports

Grants Pass, Oregon, 97527, United States

Location

Coastal Orthopedic Associates

Conway, South Carolina, 29526, United States

Location

Unlimited Research

San Antonio, Texas, 78217, United States

Location

Arthritis Northwest

Seattle, Washington, 98166, United States

Location

Sir William Osler Health Institute

Hamilton, Ontario, L9C 7N4, Canada

Location

Clinique du Sport

Mérignac, 33700, France

Location

Centre Hospitalier Lyon-Sud, Service de Rhumatologie

Pierre-Bénite, 69495, France

Location

CHU Hôpital Trousseau Service de Rhumatologie

Tours, 37044, France

Location

St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis

Heidelberg, 69121, Germany

Location

Orthopaedische Gemeinschaftspraxis

Weyhe-Kirchweyhe, 28844, Germany

Location

Southampton General Hospital, MRC Environmental Epidemiology Unit

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Maidstone General Hospital & Tunbridge Wells NHS Trust

Maidstone, Kent, ME16 9QQ, United Kingdom

Location

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

Leytonstone, London, E11 1NR, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 31, 2005
• Study Start: October 1, 2004
• Study Completion: September 1, 2007
• Last Updated: February 5, 2014

Record last verified: 2014-02

Locations

FR (3); US (15); DE (2); GB (3); CA (1)