Diacerein as Adjuvant to Diclofenac Sodium in Indian Patients of Osteoarthritis (OA) Knee
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase 4 Study of Diacerein as Adjuvant to Diclofenac Sodium in Indian Patients of OA Knee|
- Visual Analogue scale assessment of pain . [ Designated as safety issue: No ]
- WOMAC assessment of pain, physical function
- Global patient and physician assessment of pain and function
- Paracetamol consumption
|Study Start Date:||January 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
diacerein 50mg oD first month, 50 mg BD next 2 months
Diclofenac sodium 75mg sustained release tablet once daily was given to both groups for 3 months. Capsule diacerein 50mg in study group and matched placebo in control group were given once daily for first month and twice daily for next two months with the main meals.
Currently symptomatic relief is provided by the use of nonsteroidal anti-inflammatory drugs (NSAIDs) but they do not reverse the basic pathology of disease, rather may accelerate it, like degeneration of cartilage, inhibition of chondroitin synthesis and suppression of proteoglycans synthesis by the chondrocyte.
Research shows that IL-1β plays a fundamental role in osteoarthritis pathophysiology and cartilage destruction. Diacerein, a purified compound with anthraquinonic structure, inhibits IL-1β, retarding all pathological processes initiated in OA. Also, Diacerein has proven analgesic efficacy comparable to that of diclofenac in patients of osteoarthritis knee12. Because of these factors, the present study has been planned to evaluate the clinical effectiveness of diacerein as add on therapy to diclofenac sodium in Indian patients of symptomatic OA knee.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120015
|Amritsar, Punjab, India, 143001|
|Principal Investigator:||Kuljinder Singh, MD||GMC Amritsar|
|Study Chair:||Jaswant rai, MD||GMC Amritsar|
|Study Chair:||Rakesh sharma, MS||GMC Amritsar|