Clinical Study of Non-inferiority With Participants Diagnosed With Primary Knee OA (GLACIAL)

Inclusion criteria

Male and female patients meeting all the following criteria will be enrolled in the study:

• Aged ≥ 40 years.
• Clinical and radiological diagnosis of primary (idiopathic) arthrosis of knee according to the criteria of the American College of Rheumatology (ACR).
• Kellgren and Lawrence radiological classification of degree 2 or 3 in x-ray of knee-target obtained in 3 months prior to the screening visit of the study.
• Presence of painful symptoms in the target knee in the last 3 months due to osteoarthritis.
• Visual analogue scale for evaluation of the pain of osteoarthritis of knee by the research participant in the screening visit ≥ 40 mm
• Average score ≥ 40 mm in the subscale of "pain" (from 0 to 100 mm) in the target knee of the questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in the randomization visit.
• Functional class ACR from I to III.
• Signing the Informed Consent Form (ICF) before the performance of any study procedure.

Exclusion criteria

Patients meeting at least one of the following criteria will be excluded from the study:

• Diagnosis of septic arthritis, inflammatory arthritis (as rheumatoid arthritis), gout, pseudogout, Paget's disease, dysplasias or congenital joint abnormalities.
• Presence of inflammatory signals (edema, erythema or joint effusion) in the target knee, considered to be clinically significant by investigator.
• Serious target knee joint misalignment, defined by investigator.
• Predominantly patellofemoral Osteoarthritis in the target knee.
• Historical of severe trauma or surgery (including arthroscopy) in the target knee in the 6 months before the screening visit.
• Planned Surgery to the target knee
• Symptomatic Osteoarthritis of the ipsilateral hip.
• Use of non-steroidal anti-inflammatory, dipyrone and opioid analgesics or narcotics from the screening visit, or a washout period for these medicines less than those defined by the Protocol, before the randomization visit .
• Oral Glucocorticoids, intravenously or intramuscularly in the 30 days prior to the screening visit.
• Intraarticular corticosteroid Injection and/or hyaluronic acid in the target knee in 6 months prior to the screening visit.
• Use of the following drugs in the periods described below, before the screening visit:

• Diacerein, chloroquine or soybean and avocado unsaponifiables extracts in the last 3 months.
• Duloxetine hydrochloride in the last 30 days.
• Glucosamine Sulphate and/or chondroitin sulfate in the last 6 months.
• Strontium ranelate for the past 6 months.
• Historical of allergy or intolerance to treatment of the study or to paracetamol.
• Physiotherapy or irregular practice of physical activity beginning in the 3 months prior to the screening visit.
• Diagnosis of fibromyalgia, collagenosis or significative vascular/neurologica diseases in lower limbs that may confuse the analysis of the study.
• Body mass index ≥ 40 kg/m2.
• Need to use cane, crutches or a walker.
• Presence of infectious hepatitis active or history of hepatitis medicinal products.
• Results of ALT, AST and total bilirubin and fractions above the upper limit of normal.
• Serum creatinine level above the upper limit of normal.
• Fasting blood glucose > 110 mg/dL or glycated hemoglobin > 6.5%.
• Use of anticoagulants.
• Consumption of alcohol more than one dose a day (women) or two doses a day (men).
• Presence of serious diseases or not controlled.
• Planned surgery to occur during the period of participation in the study.
• Presence of pregnancy or breastfeeding.
• Women of childbearing potential must agree to use highly effective contraception.
• Participation in a clinical trial protocol within the previous 12 months unless, at the investigator's discretion, his or her participation may imply a direct benefit for the participant.
• Presence of any condition which, at the investigator's discretion, may consider the participation of the patient inadequate for the study.