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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:
ClinicalTrials.gov Identifier:
NCT00131300
First Posted: August 18, 2005
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
August 17, 2005
August 18, 2005
March 18, 2015
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
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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
 
NCT00131300
SYNV-002-01
Not Provided
Not Provided
Not Provided
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
March 2015

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