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
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- 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)
研究概览
简要总结
Objective: The aim of this study was to compare the effectiveness and tolerability of a fixed ?dose combination (FDC) of diacerein 50 mg + aceclofenac 100 mg BID and aceclofenac 100 mg BID in adult Indian patients with Osteoarthritis(OA) of the knee.Methods: This 6-week, double-blind, randomized, comparative, multicenter study was undertaken to compare oral diacerein +aceclofenac and aceclofenac alone in patients with OA after obtaining their informed consent. Participants completed the WOMAC-OA, WOMAC ?CI (for pain, stiffness, and physical function), and a visual analog scale (VAS) at each study visit. The primary end points were the WOMAC-OA, the WOMAC -CI, and VAS scores for pain among the patients who completed the study. The fixed ?dose combination of diacerein + aceclofenac was better than aceclofenac in effectiveness
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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)
时间窗: Baseline, Weeks 2, 4 and 6
次要结局
- Improvement in Patient?s and Physician?s Global Assessment of Arthritis.(Baseline, Weeks 2, 4 and 6)