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
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 April 23, 2014