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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00139295
First received: August 29, 2005
Last updated: February 4, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139295

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

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00139295     History of Changes
Other Study ID Numbers: AVS00103
Study First Received: August 29, 2005
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi:
musculoskeletal
osteoarthritis of the knee

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

ClinicalTrials.gov processed this record on August 18, 2014