Clinical trial: Efficacy and Safety of Glucosamine Sulfate and Chondroitin Sulfate Combination in Treatment of Knee Osteoarthritis (NCT02010918)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment