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 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment