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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Hylastan
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring musculoskeletal, osteoarthritis of the knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Capstone Clinical Trials, Inc
  • Hope Research Institute, LLC
  • Tucson Orthopedic Institute, PC
  • Orthopaedic Specialties of Tampa Bay
  • Northwestern Center for Clinical Research
  • Midwest Orthopedics at Rush University Medical Center
  • Rockford Health Physicians
  • Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research
  • Orthopedic Specialists of Louisiana
  • Arthritis & Osteoporosis Center of Maryland
  • Clinical Pharmacology Study Group
  • Orthopedic Center for Joint Replacement and Sports
  • Coastal Orthopedic Associates
  • Unlimited Research
  • Arthritis Northwest
  • Sir William Osler Health Institute
  • Clinique du Sport
  • Centre Hospitalier Lyon-Sud, Service de Rhumatologie
  • CHU Hôpital Trousseau Service de Rhumatologie
  • St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis
  • Orthopaedische Gemeinschaftspraxis
  • Southampton General Hospital, MRC Environmental Epidemiology Unit
  • Maidstone General Hospital & Tunbridge Wells NHS Trust
  • Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department

Outcomes

Primary Outcome Measures

pain relief

Secondary Outcome Measures

Full Information

First Posted
August 29, 2005
Last Updated
February 4, 2014
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00139295
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
musculoskeletal, osteoarthritis of the knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Hylastan
Primary Outcome Measure Information:
Title
pain relief

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Capstone Clinical Trials, Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Hope Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Tucson Orthopedic Institute, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Orthopaedic Specialties of Tampa Bay
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Northwestern Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Midwest Orthopedics at Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rockford Health Physicians
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61103
Country
United States
Facility Name
Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Orthopedic Specialists of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Arthritis & Osteoporosis Center of Maryland
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Orthopedic Center for Joint Replacement and Sports
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Facility Name
Coastal Orthopedic Associates
City
Conway
State/Province
South Carolina
ZIP/Postal Code
29526
Country
United States
Facility Name
Unlimited Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Arthritis Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Sir William Osler Health Institute
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9C 7N4
Country
Canada
Facility Name
Clinique du Sport
City
Merignac
ZIP/Postal Code
33700
Country
France
Facility Name
Centre Hospitalier Lyon-Sud, Service de Rhumatologie
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Hôpital Trousseau Service de Rhumatologie
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis
City
Heidelberg
ZIP/Postal Code
69121
Country
Germany
Facility Name
Orthopaedische Gemeinschaftspraxis
City
Weyhe-Kirchweyhe
ZIP/Postal Code
28844
Country
Germany
Facility Name
Southampton General Hospital, MRC Environmental Epidemiology Unit
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Maidstone General Hospital & Tunbridge Wells NHS Trust
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department
City
Leytonstone
State/Province
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom

12. IPD Sharing Statement

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

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