A clinical trial to study the effects of two different formulations of diacerein in patients with osteoarthritis of the knee.
- Registration Number
- CTRI/2009/091/000300
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>Timepoint: Baseline and at 2, 4, 6 and 8 weeks
- Secondary Outcome Measures
Name Time Method Improvement in Patient?s and Physician?s Global Assessment of Arthritis.Timepoint: At the end of the study at Week 8.