Clinical trial: Non-inferiority Study of the Glucosamine Sulfate + Chondroitin Sulfate Association Capsule in Comparison to the CONDROFLEX® Product in Osteoarthrosis of the Knee (NCT01172249)

Eligibility criteria:
Inclusion Criteria:

          -  Individuals must have 55-80 years of age, of both sexes and all races.

          -  Individuals diagnosed with osteoarthritis in the knee with grades 2 to 3 according to
             the scale of Kellgren / Lawrence [K / L], in conjunction with the measurement of Joint
             Space Width (JSW), which considers the joint space width, confirmed by radiological
             examination (s) of the knee (s) affected (s).

        Grade 1: doubtful narrowing of joint space and possible osteophyte edge Grade 2: defined
        osteophytes, moderate joint space narrowing Grade 3: moderate multiple osteophytes,
        definite reduction in joint space, some sclerosis and possible deformity of bone contour
        Grade 4: large osteophytes, marked joint space narrowing, severe sclerosis and definite
        deformity of bone contour

          -  Individuals with the capacity to provide a written informed consent, understand and
             respond to the questionnaires during the study about their disabilities and also with
             a willingness to adhere to treatment and attend the scheduled appointments for the
             study.

          -  Persons who have observed the period of wash-out of the drugs listed in question
             Prohibited Medication

        Exclusion Criteria:

          -  Individuals with a history of hypersensitivity to glucosamine sulfate and chondroitin
             sulfate or any of the components of the formula

          -  Individuals who have used any drug in research within the last 30 days

          -  Individuals with uric acid greater than or equal to 6 mg/dL for women and 7 mg/dL for
             men or a previous diagnosis of gout and/or on hypouricemic medication

          -  Individuals who are in physical therapy

          -  Individuals with bilateral osteoarthritis, in whom the classification of one of the
             knees does not fit into grade 2 or 3, according to the scale Kellgren / Lawrence (K/L)
             together with the measure of Joint Space Width (JSW)

          -  Individuals being treated with glucocorticoid infiltration, or who have injected
             hyaluronic acid in the joint

          -  Individuals who underwent arthroplasty in any location to be evaluated

          -  Individuals with thyroid dysfunctions that are not controlled (these can only be
             included in the presence of a normal TSH)

          -  Subjects with decompensated type 2 diabetes mellitus (diagnosed by examination
             glycated hemoglobin, which should be below 7.5%)

          -  Individuals with infection (known or suspected) in the joints that require therapy
             with systemic antibiotics

          -  Individuals with significant diseases or clinically significant disorder which,
             according to the investigator, could interfere with the study or require treatment
             that might interfere with assessment of efficacy and / or safety

          -  Individuals who have knowledge of being HIV positive or are immunocompromised

          -  Patients who need to use some of the medications listed in item Forbidden Medication

          -  Individuals with other neurological or orthopedic alteration that affects the lower
             limbs

          -  Individuals with a BMI (Body Mass Index) greater than 27

          -  Individuals should not initiate physical activity after the inclusion of the study. If
             they are already doing regular activities before entering the study, the patient may
             be included as long as he keeps the activities

          -  Individuals with kidney disease.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 80 Years

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? 1