Clinical trial NCT02010918 (phase 3, status: completed)
Conditions: knee osteoarthritis
ICD codes: M17.9, M17.0, M17.10, M17.11, M17.12, M17.2, M17.30
Drugs: glucosamine sulfate /chondroitin sulfate - capsules, glucosamine sulfate /chondroitin sulfate - sachet, cosamin ds®
SMILES: N[C@H]1C(O)O[C@H](CO)[C@@H](O)[C@@H]1O, N[C@H]1C(O)O[C@H](CO)[C@@H](O)[C@@H]1O
Eligibility 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:

               1. Pain on movement of the affected knee for more than 15 days in the previous month
                  with at least partial relief at rest;

               2. 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.