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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00377624 |
Three-arm, parallel, double-blind, masked observer, randomized, PB-Saline controlled clinical trial. In order to avoid problems in the interpretation of the final results due to disparate enrollment from various centers, the number of patients enrolled per site will be the same per site. Study patients will be randomized to receive either 20 mg sodium hyaluronate, 3 i.a. sodium hyaluronate injections, followed by 2 PBSaline mock i.a. injections or 5 i.a. PB-Saline control injections. One investigator will administer the injection and the joint assessor will be blinded to the study. The anterior or posterior approach for the shoulder injection will be used.
Condition | Intervention | Phase |
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Osteoarthritis of Shoulder |
Drug: sodium hyaluronate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Sodium Hyaluronate for Treatment of Chronic Painful Shoulder With Limitation of Motion Due to Glenohumeral Joint Osteoarthritis, Rotator Cuff Tear and/or Primary or Secondary Adhesive Capsulitis |
Estimated Enrollment: | 602 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | September 2004 |
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
INCLUSION CRITERIA:
EXCLUSION CRITERIA
A. GENERAL MEDICAL CONDITIONS
B. MUSCULOSKELETAL RELATED
C. CONCOMITANT CONDITIONS, DISEASES, MEDICATIONS AND/OR CLINICAL HISTORY.
Study ID Numbers: | L-8229 |
Study First Received: | September 14, 2006 |
Last Updated: | November 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00377624 |
Health Authority: | United States: Food and Drug Administration |
Lacerations Musculoskeletal Diseases Hyaluronic Acid Osteoarthritis Joint Diseases |
Arthritis Neoplasm Metastasis Pain Rheumatic Diseases |
Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |