Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip

Laboratoires NEGMA500 enrolled

Overview

We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to: * evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis * to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis This study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

500

Conditions

Hip Osteoarthritis

Interventions

diacereinDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Outpatients fulfilling the American College of Rheumatology criteria for the diagnosis of hip osteoarthritis. * Lequesne algofunctional index of at list 3 points. * Radiographic criterion for inclusion: joint space width (JSW) between 1 mm and 3 mm. If the JSW exceeded 3 mm, it had to be at least 0.5 mm thinner than JSW of the contra lateral hip, measured at its narrowest point. Exclusion Criteria: * Intraarticular injection or arthroscopy of the hip during the three months prior to inclusion in the study. * Any systemic or intraarticular corticosteroid as well as other potential symptom-modifying drugs for osteoarthritis were not allowed during the study.

Locations (25)

Hôpital Nord

Amiens, France

Hôpital Pellegrin

Bordeaux, France

Outcomes

Primary Outcomes

Joint space measurement

Secondary Outcomes

Requirement of hip replacement surgery after ten years

Tolerability

Data from ClinicalTrials.gov

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