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Sponsored by: |
Northwestern Ophthalmic Institute S.C. |
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Information provided by: | Northwestern Ophthalmic Institute S.C. |
ClinicalTrials.gov Identifier: | NCT00253799 |
The objective is to assess the safety and efficacy (over the course of 26 weeks) of 2 intra-articular (IA) Hylan GF-20 (Synvisc) injections in addition to customary care in patients with painful glenohumeral osteoarthritis.
Condition | Intervention | Phase |
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Painful Shoulder Osteoarthritis |
Device: Hylan GF-20 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Single Arm, Pilot Study Evaluating the Safety and Efficacy of Hyaluronan (Hylan GF-20) in Patients With Painful Shoulder Osteoarthritis |
Estimated Enrollment: | 35 |
Study Start Date: | December 2005 |
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
• Be will and able to provide written informed consent prior to any study-related procedures being performed and able to understand and comply with the requirements of this study.
Exclusion Criteria:
• Pregnant, lactating, or unwilling to use adequate contraception.
Study ID Numbers: | 0133-003 |
Study First Received: | November 10, 2005 |
Last Updated: | June 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00253799 |
Health Authority: | United States: Institutional Review Board |
Musculoskeletal Diseases Hyaluronic Acid Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases |