A RANDOMIZED, ACTIVE CONTROLLED, CLINICAL TRIAL TO ASSESS THE EFFICACY AND SAFETY OF CELECOXIB + DIACEREIN FIXED DOSE COMBINATION IN ADULT INDIAN PATIENTS SUFFERING FROM OSTEOARTHRITIS

Abstract

Background: Osteoarthritis of knee and/or hip joints is a common disorder associated with a significant morbidity in the elderly patients. Celecoxib + Diacerein Fixed Dose Combination (FDC) can be a useful medication for the treatment of osteoarthritis of knee and/or hip joints. Objective: To compare efficacy and safety of Celecoxib + Diacerein FDC capsules given twice daily with Aceclofenac + Diacerein FDC tablets given twice daily in the management of osteoarthritis of knee and/or hip joints in adult Indian patients. Methods: Clinically symptomatic patients with osteoarthritis of knee and/or hip joints were randomized to treatment with Celecoxib 100 mg + Diacerein 50 mg FDC capsules or Aceclofenac 100 mg + Diacerein 50 mg FDC tablets each given twice daily for 4 weeks in this comparative clinical trial. Efficacy assessments were carried out using pre-validated SAS (Short Arthritis Assessment Scale) questionnaire. Results: Celecoxib + Diacerein FDC capsules (n=12) produced significant improvement in Pain, Physical Function & Overall well-being aspects of SAS questionnaire at the end of treatment period as compared to baseline (p<0.05 for all). Similar results were obtained with Aceclofenac + Diacerein FDC tablets (n=13); there was no statistically significant difference between the two treatment groups. Celecoxib + Diacerein FDC capsules were excellently tolerated and none of the patients enrolled in either of the groups reported any adverse event. Conclusion: Celecoxib + Diacerein FDC capsules are equally efficacious as Aceclofenac + Diacerein FDC tablets and excellently tolerated for the treatment of osteoarthritis of knee and/or hip joints in adult Indian patients.