Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Menarini Group
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients aged 40 to 80 years with BMI \< 30 kg/m²
Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
You may not be if
History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
Any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study
Use of systemic or topical corticosteroids \> 10 mg prednisolone equivalent per day, or immunosuppressant drugs
Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
Viscosupplementation to the target knee administered \< 4 months prior to randomisation and/or scheduled during the course of the study
Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
Patients with any clinically relevant or unstable disease, or malignant neoplasms that, in the opinion of the Investigator, may pose the patient at risk, or confound the efficacy and safety results of the study
Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
Pregnant and breastfeeding women
Any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
Patients with bleeding diathesis or on therapy with anticoagulants
