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

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ClinicalTrials.gov Identifier: NCT00139295
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : February 5, 2014
Sponsor:
Information provided by:
Sanofi

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Hylastan Phase 3

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : October 2004
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources




Primary Outcome Measures :
  1. pain relief


Information from the National Library of Medicine

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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

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

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00139295     History of Changes
Other Study ID Numbers: AVS00103
First Posted: August 31, 2005    Key Record Dates
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