Background/Purpose:  For the assessment of Symptomatic Slow Acting Drugs in Osteoarthritis (SYSADOAs), regulatory Agencies request the assessment of two co-primary endpoints: pain and function. They also recommend the design of three-arm studies including the investigational drug, a placebo and an active comparator.

Methods:  The CONCEPT study investigated the symptomatic effects of pharmaceutical grade Chondroitin Sulfate (CS) (800 mg/day), Celecoxib (CE) (200 mg/day) and a placebo (PL) in a double-blind, double-dummy Phase III clinical trial.

Results:  604 patients recruited in 5 European countries, with knee osteoarthritis (OA) in accordance with the ACR criteria, were followed for 182 days. In the intention to treat analysis, pain (VAS) was significantly reduced, at D182, in the CS ( -52%) and in the CE ( -52%) compared to PL ( -42%) (P < 0.05 for both). No differences were observed between CS and CE. The Lequesne index, measuring pain and function, showed similar results with CS ( -37%) and CE ( -36%) being significantly different from PL ( -28%) (P < 0,05 for both) and no difference between CS and CE. Similar results were observed for the Minimum Clinically Important Improvement (MCII) and Patient Acceptable Symptoms State (PASS) at D182 for the intention to-treat and per-protocol populations. Safety analyses showed no significant differences between the three groups.

Conclusion:  Pharmaceutical grade Chondroitin Sulfate, at the dose of 800 mg/day, reduced pain and improved function to the same extent as Celecoxib and significantly more than placebo, in patients with knee osteoarthritis.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/pharmaceutical-grade-chondroitin-sulfate-improves-knee-osteoarthritis-symptoms-more-than-placebo-and-as-much-as-celecoxib-results-of-the-chondroitin-vs-celecoxib-vs-placebo-trial-concept/