A Study of the Safety and Efficacy of Synvisc and Depo-Medrol in Patients With Osteoarthritis of the Hip

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00131326
First received: August 17, 2005
Last updated: August 3, 2009
Last verified: February 2007
  Purpose

This is a clinical study to investigate the safety and efficacy of Synvisc and Depo-Medrol in treating patients with osteoarthritis (OA) of the hip.


Condition Intervention Phase
Osteoarthritis, Hip
Musculoskeletal Diseases
Device: Synvisc (hylan G-F 20)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • Pain relief

Study Start Date: November 2003
Estimated Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with symptomatic osteoarthritis pain of hip

Exclusion Criteria:

  • Patients with current or prior conditions or treatment that would impede measurement of efficacy and safety
  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: NCT00131326

  Show 32 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: NCT00131326     History of Changes
Other Study ID Numbers: SYNV-004-02
Study First Received: August 17, 2005
Last Updated: August 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
osteoarthritis of the hip
Musculoskeletal Diseases

Additional relevant MeSH terms:
Musculoskeletal Diseases
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014