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CompletedNCT00139295Updated Feb 5, 2014

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

A Phase 3 interventional study of Hylastan in Osteoarthritis, Knee, sponsored by Genzyme, a Sanofi Company. Completed at 24 sites in 5 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-02-05.

Sponsored by Genzyme, a Sanofi Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.

02

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • musculoskeletal
  • osteoarthritis of the knee
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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

Browse Osteoarthritis studies →

Lead sponsor

Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Prior or concomitant treatments that would impede measurement of safety and efficacy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • DeviceHylastan
06

What researchers measure

Primary outcomes

  1. pain relief

07

Study locations

24 sites
  • Capstone Clinical Trials, Inc
    Birmingham, Alabama 35209, United States
  • Hope Research Institute, LLC
    Phoenix, Arizona 85050, United States
  • Tucson Orthopedic Institute, PC
    Tucson, Arizona 85712, United States
  • Orthopaedic Specialties of Tampa Bay
    Clearwater, Florida 33756, United States
  • Northwestern Center for Clinical Research
    Chicago, Illinois 60611, United States
  • Midwest Orthopedics at Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Rockford Health Physicians
    Rockford, Illinois 61103, United States
  • Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research
    Lexington, Kentucky 40509, United States
  • Orthopedic Specialists of Louisiana
    Shreveport, Louisiana 71101, United States
  • Arthritis & Osteoporosis Center of Maryland
    Frederick, Maryland 21702, United States
  • Clinical Pharmacology Study Group
    Worcester, Massachusetts 01610, United States
  • Orthopedic Center for Joint Replacement and Sports
    Grants Pass, Oregon 97527, United States
  • Coastal Orthopedic Associates
    Conway, South Carolina 29526, United States
  • Unlimited Research
    San Antonio, Texas 78217, United States
  • Arthritis Northwest
    Seattle, Washington 98166, United States
  • Sir William Osler Health Institute
    Hamilton, Ontario L9C 7N4, Canada
  • Clinique du Sport
    Merignac, 33700, France
  • Centre Hospitalier Lyon-Sud, Service de Rhumatologie
    Pierre Benite Cedex, 69495, France
  • CHU Hôpital Trousseau Service de Rhumatologie
    Tours, 37044, France
  • St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis
    Heidelberg, 69121, Germany
  • Orthopaedische Gemeinschaftspraxis
    Weyhe-Kirchweyhe, 28844, Germany
  • Southampton General Hospital, MRC Environmental Epidemiology Unit
    Southampton, Hampshire SO16 6YD, United Kingdom
  • Maidstone General Hospital & Tunbridge Wells NHS Trust
    Maidstone, Kent ME16 9QQ, United Kingdom
  • Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department
    Leytonstone, London E11 1NR, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00139295
Lead sponsor
Genzyme, a Sanofi Company
First posted
Aug 31, 2005
Start date
Oct 2004
Completion
Sep 2007
Last update
Feb 5, 2014

Study contacts

Medical Monitor
study director · Genzyme, a Sanofi Company
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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