- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00131300
A Study of the Safety and Efficacy of Synvisc in Patients With Symptomatic Shoulder Osteoarthritis
March 17, 2015 updated by: Genzyme, a Sanofi Company
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Boulogne-Billancourt, France, 92100
- Hopital Ambroise Pare
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Lyon, France, 69003
- Clinique Saint Anne Lumiere
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Merignac, France, 33700
- Centre de Medecine et Traumatologie du Sport Clinique du Sport
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Tours, France, 37044
- CHRU Hopital Trousseau
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Bad Oeynhausen, Germany, 32545
- August-Viktoria-Klinik
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Halle/Saale, Germany, 06097
- Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Pain relief
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Study Completion
February 1, 2006
Study Registration Dates
First Submitted
August 17, 2005
First Submitted That Met QC Criteria
August 17, 2005
First Posted (Estimate)
August 18, 2005
Study Record Updates
Last Update Posted (Estimate)
March 18, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYNV-002-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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