CTRI/2010/091/000081
Completed
Phase 3
Comparative Assessment Of The Efficacy, Safety And Tolerability Of Fixed Dose Combination Of Diacerein Plus Aceclofenac With Aceclofenac In Adult Patients With Osteoarthritis Of The Knee
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Glenmark Pharmaceuticals Ltd
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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