None listed
Conditions
Interventions
Intervention1: Diacerein MR: 100 mg once daily for 8 weeks
Control Intervention1: Diacerein IR: 50 mg twice daily
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Western Ontario and McMasters (WOMAC) individual osteoarthritis (OA) indices and Composite Index (for pain, stiffness and physical function) and Visual Analog Scale (VAS) scores(for pain) Timepoint: Baseline and at 2, 4, 6 and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Patient?s and Physician?s Global Assessment of Arthritis.Timepoint: At the end of the study at Week 8. | — |
Countries
India
Contacts
Public ContactChandrashekhar S Bolmall
Glenmark Pharmaceuticals Ltd
Outcome results
None listed