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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00130468 |
This study will evaluate the efficacy and safety of intra-articular injections of 20 mg/2mL dose HYALGAN in patients with pain due to osteoarthritis (OA) of the knee.
Condition | Intervention | Phase |
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Osteoarthritis |
Drug: Hyalgan (sodium hyaluronate) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind, Randomized Trial of Intra-Articular Injections of 20 mg of Hyalgan® for the Treatment of Knee Pain Due to Osteoarthritis (Three Injection-Regimen for Efficacy And Duration-20 mg/2mL Dose: Tread-20) |
Estimated Enrollment: | 150 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | May 2006 |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with signs and symptoms of osteoarthritis of at least one knee:
Exclusion Criteria:
Women of childbearing potential may not be entered if:
Musculoskeletal Related
Concomitant conditions, diseases, medications and/or clinical history
Study ID Numbers: | L_9385 |
Study First Received: | August 12, 2005 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00130468 |
Health Authority: | United States: Institutional Review Board |
Musculoskeletal Diseases Hyaluronic Acid Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases |
Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |