LONDON, June 13, 2016 /PRNewswire/ --
- A new clinical study, conducted in full compliance with the most recent EMeA (European Medicines Agency) guidelines, shows that prescription chondroitin sulphate reduces pain and improves functional disability significantly better than placebo in patients with knee osteoarthritis (OA)
- Chondroitin sulphate proves to be equally effective as the anti-inflammatory drug (NSAID) celecoxib
- Patients treated daily, for 6 months, well tolerated chondroitin sulphate 800 mg oral dosage form. No serious treatment-related side effects were reported during the entire period of the study
IBSA, in occasion of the European Congress of Rheumatology (EULAR 2016), has presented the results of a new multicentre, randomised, double-blind and double-dummy phase III clinical trial named CONCEPT (ChONdroitin vs CElecoxib vs Placebo T rial).
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The study, designed in full compliance with the most recent EMeA guidelines, was conducted in 16 centers located in Belgium, Czech Republic, Italy, Poland and Switzerland and involved 603 patients with knee OA with the aim to confirm the efficacy and the safety of prescription highly purified chondroitin sulphate versus placebo and celecoxib, as gold reference standard, for a 6-month treatment period.
The results, presented by Prof. Reginster, MD, PhD, Professor of Epidemiology, Public Health and Health Economics (University of Liege, Belgium), during IBSA satellite symposium "What treatment should we adopt as the preferred long-term therapy in knee OA" (http://www.ibsa-international.com/eular2016) show that the two primary endpoints, the decrease of the Lequesne algo-functional index and the decrease of pain on a VAS scale, resulted both to be statistically significant (p