MedTrace Logo

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

NCT02688400 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2023-12-01

Study results available
· View outcomes & findings →

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).

Conditions

Interventions

DRUG

Diacerein

DRUG

Celecoxib

DRUG

Placebo

Sponsors & Collaborators

  • ArthroLab Inc.

    collaborator INDUSTRY

  • TRB Chemedica International SA

    lead INDUSTRY

Principal Investigators

  • Jean-Pierre Pelletier, MD, FRCPC · ArthroLab Inc.

  • Jean-Pierre Raynauld, MD, FRCPC · Osteoarthritis Research Unit, University of Montreal Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-06-26
Completion
2018-06-28

Countries

  • Austria
  • Belgium
  • Canada
  • Czechia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02688400 on ClinicalTrials.gov