Phase 3, duble-blind, randomized, parallel study to evaluate the efficacy of glucosamine sulfate and meloxicam administered in combination or glucosamine sulfate and meloxicam administered separately to subjects with mild to moderate osteoarthiritis of the knee or hip

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Arthritis is a generic term that refers to the inflammatory process that occurs in one or more joints. Among the causes of arthritis, the osteoarthritis (OA), also called osteoarthrosis, it’s the most frequent one (Myers e cols., 2007). Previously considered to be a degenerative disease, OA is known today as a metabolically dynamic disease, with repairing mechanisms that involve the cartilage and the underlying bone tissue of the joints (Jones & Doherty, 1995). OA is a result of mechanical or biological events that interfere with the delicate balance between production and degradation of the cartilage tissue and the bone immediately beneath it. It attacks all the joint tissues and it is characterized by morphological, biochemical, molecular and biomechanical changes. Over the last few years, the possible treatments for OA have been largely studied all over the world. All these studies strive to provide a drug or a therapeutic combination that brings more comfort to the patient and improves his or her quality of life. In this sense, the ultimate goal is to alleviate symptoms of pain (acute or chronic), increase functional physical capacity and help repair the affected cartilage. Pre-clinical studies had shown that orally absorbed glucosamine helps restitute the components lost during natural degradation of OA and increases production of proteoglicans by the chondrocytes when associated with Meloxicam. Combination of an anti-inflammatory / analgesic drug and a cartilage regenerator like SYSADOA (SYmptomatic Slow-Acting Drugs in Osteoarthritis) is the objective for a more complete approach in the treatment of OA. The proposed therapy with this new association aims to keep work capacity in young adults (40 to 60 years old) that have the chronic and potentially incapacitating form of the disease. The purpose of this study is to compare, after 12 weeks of double-blind oral administration of this therapy, the physical activity rate achieved by the subjects assigned to the different therapeutic branches, which will be analyzed by the WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire filled out by individuals with knee or hip OA of mild to moderate intensity and not exposed to previous treatment.

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