Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis

The Groups receive treatment for 16 weeks. The study is realized in 16 sites in Brazil.

Inclusion criteria

• Male or female patient, older than 40 years of age, with knee osteoarthritis, based on clinical and radiological criteria (Kellgren-Lawrence grade 2 - 3), as specified:

• Pain on movement of the affected knee for more than 15 days in the previous month with at least partial relief at rest;
• Presence of osteophytes at least 1 mm in radiological imaging;
• Knee osteoarthritis symptoms for at least six months prior to randomization.

Exclusion criteria

• Concomitant arthropathy that may confuse or interfere with assessing the efficacy or pain;
• Patellar disease isolated, with primary symptoms of pain in the anterior knee, in the absence of radiological findings already described;
• History of significant injury on collateral ligament, or anterior cruciate, or meniscus of the joint studied, with surgery, or immobilization for at least 3 weeks;
• Arthroscopy of the affected knee in last 6 months;
• Serum creatinine ≥ 1.8 mg/dL;
• Diagnosis of diabetes mellitus;
• Presence of any serious disease that could compromise the study, at the investigator discretion;
• History of adverse event or allergy to acetaminophen, glucosamine sulfate or chondroitin sulfate;
• Inability to understand and report the study questionnaire and the Visual Analogic Scale;
• Inability to understand and consent to participate in this clinical study, expressed by signing the Informed Consent (IC);
• Woman in pregnancy.
• If female of childbearing potential, has a negative urine pregnancy test at Visit 0 and do not use, or do not agree to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator;
• Alcohol intake ( > 3 doses/day);
• Oral or intramuscular corticosteroids four weeks prior to study entry;
• Intra-articular injections with corticosteroids, into the studied knee, within the past three months;
• Intra-articular injections in any other joint within the past four weeks;
• NSAID users that don´t respect the washout period. Low-dose aspirin (325 mg or less, once daily) is allowed for cardio-protective benefit;
• Intra-articular injections of hyaluronic acid within the past 12 months;
• Use of topical analgesic in the joint studied or any other oral analgesic (with the exception of acetaminophen and other NSAID) two weeks prior to randomization;
• Implementation of any other medical treatment for osteoarthritis one month prior to study entry;
• Participation in last one year of clinical protocols, unless it can be direct benefit to patient;
• Use of glucosamine and/or chondroitin sulfate three and six months prior the study entry, respectively;
• Initiation of physical therapy two months prior to the study period;
• Use of tetracycline and oral anticoagulants;
• Use of vitamin D in doses in doses above the recommended;
• Patients in alternative therapies;
• Allergy to sulfonamides;
• Presence of psychiatric disorders that could compromise the study.