COMPARATIVE ASSESSMENT OF THE EFFICACY, SAFETY AND TOLERABILITY OF DIACEREIN MR 100mg vs DIACEREIN 50mg IN ADULT PATIENTS WITH OSTEOARTHRITIS OF THE KNEE

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 210 人开始时间: 待定最近更新: 2021年11月24日

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•Males and non-pregnant females (with negative beta-human chorionic gonadotropin test). Female patients on adequate contraceptive control.
•Age: 30 to 70 years
•Clinical and radiological diagnosis of osteoarthritis of the knee based on the American College of Rheumatology (ACR) Clinical Classification Criteria [Appendix B].
•Patients with a baseline Patient?s Assessment of Arthritis Pain-VAS score of > 40mm / 4cm, and both Patient?s and Physicians? Global Assessment of Arthritis of poor or very poor.
•Patient willing to comply with study procedures and requirements.

•Pregnant and nursing women.
•Patients hypersensitive to any study medications and ingredients
•Inflammatory arthritis, gout, pseudogout, Paget?s disease or any chronic pain syndrome that may interfere with assessment of the Index hip and/or knee.
•Symptomatic bursitis or acute joint trauma of the Index hip and/or knee.
•Conditions predisposing to gastrointestinal dysfunction (eg, history of peptic ulcer, upper gastrointestinal disease, ulcerative colitis; smoking; advancing age; concurrent corticosteroids; alcohol abuse; etc.).
•History of bleeding tendencies, cirrhosis and esophageal varices.
•History of hypersensitivity or allergy to NSAIDs, other COX-2 inhibitors and/or sulphonamides.
•Pre-existing asthma.
•Patients who would require concomitant therapy with drugs e.g. low dose aspirin, warfarin, anti-epileptics, fluconazole (inhibitor of CYP 2C9/3A4), ketoconazole (a known inhibitor of CYP 3A4) etc.
•Immunocompromised states and patients with systemic infections.
•Patients with severe cardiac, hepatic, renal, or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g., diabetes, hypertension, collagen disorders, etc. or any other serious medical illness.
•Patients who have participated in a new drug study in the past 3 months.
•Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.

发起方

Glenmark Pharmaceuticals Ltd