NCT02688400

Effect of Diacerein vs Celecoxib on Symptoms and Structural Changes in Symptomatic Knee Osteoarthritis

An International, Multicentre, Double-blind, Randomised Study of the Effect of Diacerein vs Celecoxib on Symptoms and Structural Changes in Symptomatic Knee Osteoarthritis Patients as Assessed by Magnetic Resonance Imaging

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: TRB Chemedica International SA · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study was a phase III (Canada and Belgium) or IV (Spain, Austria and Czech Republic) international, multicentre, double-blind, randomized, controlled, parallel-groups, symptom-modifying and structure-modifying clinical study of Diacerein (50 mg twice daily) versus Celecoxib (200 mg once daily). It was planned that 400 patients (males and females) of at least 50 years of age would take part in the study (approximately 150 patients in Canada and 250 patients in European countries). All patients were included after a Screening Visit (washout of previous medication for osteoarthritis) and randomized at the Inclusion Visit (Day 0) in 2 treatment groups of 200 patients as follows: * Diacerein arm: one 50 mg capsule taken once a day for one month and 50 mg twice daily thereafter (n = 200 patients), * Celecoxib arm: one 200 mg capsule once daily (n = 200 patients). All patients were assessed at Screening Visit (Visit 1), Inclusion (Visit 2, Day 0), Visit 3 (Day 60), Visit 4 (Day 120) and Visit 5 (Day 182 / early termination) (symptom study). The duration of the double-blind study for each patient was up to 182 ± 7 days for the symptom study. During the study, patients were allowed to take acetaminophen 500 mg, to a maximum of 2 g per day, dispensed at each visit by the investigator for rescue therapy. Pain and other functional symptoms were primary analysed after 6 months (182 days) of treatment (symptom study). Acetaminophen was dispensed during the study as rescue therapy in case of pain. However, it was asked to discontinue acetaminophen 48 hours before each study procedure/assessment of efficacy.

Conditions

• Osteoarthritis
• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Diacerein
DRUG	Celecoxib
DRUG	Placebo

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-06-26
• Completion: 2018-06-28
• First posted: 2016-02-23
• Last updated: 2023-12-01
• Results posted: 2023-12-01

Locations

22 sites across 5 countries: Austria, Belgium, Canada, Czechia, Spain