None listed
Conditions
Interventions
Intervention1: Diacerein 50 mg plus aceclofenac 100 mg: One tablet twice daily after meals for 6 weeks
Control Intervention1: Aceclofenac 100 mg: One tablet twice daily after meals
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; 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). -Visual Analog Scale (VAS) scores (for pain) Timepoint: Baseline, Weeks 2, 4 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Patient?s and Physician?s Global Assessment of Arthritis.Timepoint: Baseline, Weeks 2, 4 and 6 | — |
Countries
India
Contacts
Public ContactDr Chandrashekhar Bolmall
Medical Services
Outcome results
None listed