Clinical Drug Experience Knowledgebase

Criteria

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.