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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139295
First Posted: August 31, 2005
Last Update Posted: February 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose
This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.

Condition Intervention Phase
Osteoarthritis, Knee Device: Hylastan Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • pain relief

Study Start Date: October 2004
Study Completion Date: September 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139295


  Show 24 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00139295     History of Changes
Other Study ID Numbers: AVS00103
First Submitted: August 29, 2005
First Posted: August 31, 2005
Last Update Posted: February 5, 2014
Last Verified: February 2014

Keywords provided by Sanofi:
musculoskeletal
osteoarthritis of the knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents