Osteoarthritis, Knee Clinical Trial
Official title:
Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee
This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | September 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Sir William Osler Health Institute | Hamilton | Ontario |
| France | Clinique du Sport | Merignac | |
| France | Centre Hospitalier Lyon-Sud, Service de Rhumatologie | Pierre Benite Cedex | |
| France | CHU Hôpital Trousseau Service de Rhumatologie | Tours | |
| Germany | St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis | Heidelberg | |
| Germany | Orthopaedische Gemeinschaftspraxis | Weyhe-Kirchweyhe | |
| United Kingdom | Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department | Leytonstone | London |
| United Kingdom | Maidstone General Hospital & Tunbridge Wells NHS Trust | Maidstone | Kent |
| United Kingdom | Southampton General Hospital, MRC Environmental Epidemiology Unit | Southampton | Hampshire |
| United States | Capstone Clinical Trials, Inc | Birmingham | Alabama |
| United States | Midwest Orthopedics at Rush University Medical Center | Chicago | Illinois |
| United States | Northwestern Center for Clinical Research | Chicago | Illinois |
| United States | Orthopaedic Specialties of Tampa Bay | Clearwater | Florida |
| United States | Coastal Orthopedic Associates | Conway | South Carolina |
| United States | Arthritis & Osteoporosis Center of Maryland | Frederick | Maryland |
| United States | Orthopedic Center for Joint Replacement and Sports | Grants Pass | Oregon |
| United States | Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research | Lexington | Kentucky |
| United States | Hope Research Institute, LLC | Phoenix | Arizona |
| United States | Rockford Health Physicians | Rockford | Illinois |
| United States | Unlimited Research | San Antonio | Texas |
| United States | Arthritis Northwest | Seattle | Washington |
| United States | Orthopedic Specialists of Louisiana | Shreveport | Louisiana |
| United States | Tucson Orthopedic Institute, PC | Tucson | Arizona |
| United States | Clinical Pharmacology Study Group | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Genzyme, a Sanofi Company |
United States, Canada, France, Germany, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pain relief |
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