Clinical trial NCT00139295: Comparison of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee
Official title: Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: musculoskeletal
osteoarthritis of the knee
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-08-31
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: pain relief
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Capstone Clinical Trials, Inc
state: Alabama
city: Phoenix
country: United States
facility: Hope Research Institute, LLC
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopedic Institute, PC
state: Arizona
city: Clearwater
country: United States
facility: Orthopaedic Specialties of Tampa Bay
state: Florida
city: Chicago
country: United States
facility: Northwestern Center for Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Midwest Orthopedics at Rush University Medical Center
state: Illinois
city: Rockford
country: United States
facility: Rockford Health Physicians
state: Illinois
city: Lexington
country: United States
facility: Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research
state: Kentucky
city: Shreveport
country: United States
facility: Orthopedic Specialists of Louisiana
state: Louisiana
city: Frederick
country: United States
facility: Arthritis & Osteoporosis Center of Maryland
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Grants Pass
country: United States
facility: Orthopedic Center for Joint Replacement and Sports
state: Oregon
city: Conway
country: United States
facility: Coastal Orthopedic Associates
state: South Carolina
city: San Antonio
country: United States
facility: Unlimited Research
state: Texas
city: Seattle
country: United States
facility: Arthritis Northwest
state: Washington
city: Hamilton
country: Canada
facility: Sir William Osler Health Institute
state: Ontario
city: Merignac
country: France
facility: Clinique du Sport
city: Pierre Benite Cedex
country: France
facility: Centre Hospitalier Lyon-Sud, Service de Rhumatologie
city: Tours
country: France
facility: CHU Hôpital Trousseau Service de Rhumatologie
city: Heidelberg
country: Germany
facility: St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis
city: Weyhe-Kirchweyhe
country: Germany
facility: Orthopaedische Gemeinschaftspraxis
city: Southampton
country: United Kingdom
facility: Southampton General Hospital, MRC Environmental Epidemiology Unit
state: Hampshire
city: Maidstone
country: United Kingdom
facility: Maidstone General Hospital & Tunbridge Wells NHS Trust
state: Kent
city: Leytonstone
country: United Kingdom
facility: Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department
state: London
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: