![]() ![]() The purpose of this trial was to assess effectiveness, durability of response, time to return of pain, and safety following initial and retreatment with Gel-200. No unanticipated treatment-related serious AEs (SAEs) were reported. Reported adverse events (AEs) were comparable between Gel-200 and PBS groups. Improvements compared with PBS control were evident as soon as 3 weeks following a single injection and sustained over 13 weeks. Administration of Gel-200 resulted in statistically significant improvements in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, physical function, and physician global assessments of disease activity. ![]() 8 Effectiveness and safety of a single injection of Gel-200 through 13 weeks were demonstrated. 7 Results from a randomized, double-blind, controlled trial comparing intra-articular injection of Gel-200 with phosphate buffered saline (PBS) (initial treatment) conducted in the United States in 379 patients with OA of the knee have been previously reported. It is a sterile, transparent, viscoelastic hydrogel composed of cross-linked hyaluronate, a derivative of a highly purified sodium hyaluronate product. Gel-200 (Gel-OneĀ®, Seikagaku Corporation, Tokyo, Japan) is a single-injection intra-articular hyaluronic acid (IA-HA) approved in the United States in 2011 for the treatment of OA of the knee. 1 For more than 10 years, intra-articular injection of sodium hyaluronate has been used for treatment of pain due to knee OA and is included among recommended treatment options by several professional societies, including the Osteoarthritis Research Society International (OARSI) and the European League Against Rheumatism. Osteoarthritis (OA) is the most common arthritis, characterized by joint pain and loss of physical function.
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