Effect of Diacerein vs Celecoxib on Symptoms and Structural Changes in Symptomatic Knee Osteoarthritis
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
Osteoarthritis (OA) of the knee is the most frequent cause of knee pain after the age of 50
years. OA is a joint disease characterised by articular cartilage loss associated with
structural changes in the cartilage and adjacent structures. The main symptoms are pain and
functional disability. The goals of OA therapy are to decrease pain and maintain or improve
joint function. There is evidence that diacerein has both a symptomatic and a structural
effect on cartilage, and clinical studies suggest that diacerein therapy significantly
decreases OA symptoms when compared to placebo. Diacerein has been shown to inhibit
interleukine-1 (IL-1β), and down-regulated IL-1β stimulated secretion of metalloproteinases
and aggrecanases, and thereby prevent breakdown of cartilage by these enzymes. Diacerein has
no effect on the synthesis of prostaglandins, and therefore no effect on the upper intestinal
tract. The purpose of this phase III-IV international, multicentre, double-blind,
non-inferiority, randomised, controlled study is to determine the efficacy and safety of
diacerein vs. celecoxib on symptoms after 6 months of treatment, and on structural changes
after 2 years of treatment in knee OA patients as assessed by magnetic resonance imaging
(MRI).