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A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00131300
First received: August 17, 2005
Last updated: August 3, 2009
Last verified: November 2006

August 17, 2005
August 3, 2009
April 2004
Not Provided
Pain relief
Same as current
Complete list of historical versions of study NCT00131300 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis
Not Provided

This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis
  • Musculoskeletal Diseases
Device: Synvisc (hylan G-F 20)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
February 2006
Not Provided

Inclusion Criteria:

  • Patients with symptomatic OA pain of shoulder (gleno-humeral)

Exclusion Criteria:

  • Patients with current or prior conditions or treatment that would impede measurement of efficacy or safety
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT00131300
SYNV-002-01
Not Provided
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP