A clinical trial to study the effects of a fixed dose combination of two drugs Diacerein + Aceclofenac and aceclofenac on patients with osteoarthritis

Phase 3

Completed

• Registration Number: CTRI/2010/091/000081
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified