Back to resultsA Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis
Primary Purpose
Osteoarthritis, Musculoskeletal Diseases
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Synvisc (hylan G-F 20)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis of the shoulder, Musculoskeletal
Eligibility Criteria
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
Sites / Locations
- Hopital Ambroise Pare
- Clinique Saint Anne Lumiere
- Centre de Medecine et Traumatologie du Sport Clinique du Sport
- CHRU Hopital Trousseau
- August-Viktoria-Klinik
- Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin
Outcomes
Primary Outcome Measures
Pain relief
Secondary Outcome Measures
Full Information
NCT ID
NCT00131300
First Posted
August 17, 2005
Last Updated
March 17, 2015
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00131300
Brief Title
A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Musculoskeletal Diseases
Keywords
Osteoarthritis of the shoulder, Musculoskeletal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Synvisc (hylan G-F 20)
Primary Outcome Measure Information:
Title
Pain relief
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Ambroise Pare
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Clinique Saint Anne Lumiere
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Centre de Medecine et Traumatologie du Sport Clinique du Sport
City
Merignac
ZIP/Postal Code
33700
Country
France
Facility Name
CHRU Hopital Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
August-Viktoria-Klinik
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin
City
Halle/Saale
ZIP/Postal Code
06097
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis
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