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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 March 2015 |
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Main ID: |
NCT00131300 |
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Date of registration:
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17/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis
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Scientific title:
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Date of first enrolment:
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April 2004 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00131300 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Germany
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genzyme, a Sanofi Company |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Musculoskeletal Diseases
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Osteoarthritis
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Intervention(s)
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Device: Synvisc (hylan G-F 20)
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Primary Outcome(s)
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Pain relief
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Secondary ID(s)
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SYNV-002-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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