Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip

Phase 3

Completed

• Conditions: Hip Osteoarthritis

• Registration Number: NCT00451360
• Lead Sponsor: Laboratoires NEGMA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1993-03
• Study Completion: 1997-04
• Status Verified: 2007-03
• Study First Submitted: 2007-03-22
• Study First Submitted QC: 2007-03-22
• Study First Posted: 2007-03-23
• Last Update Submitted: 2008-07-24
• Last Update Posted: 2008-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Joint space measurement

Secondary Outcome Measures

Name	Time	Method
Requirement of hip replacement surgery after ten years
Tolerability

Trial Locations

Locations (24)

Hôpital Nord; 🇫🇷 Amiens, France

Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Ambroise Paré; 🇫🇷 Boulogne, France

CHU cote de Nacre; 🇫🇷 Caen, France

Hôpital Mondor; 🇫🇷 Créteil, France

Hôpital Général; 🇫🇷 Dijon, France

CHU; 🇫🇷 Grenoble, France

Hôpital Roger Salengro; 🇫🇷 Lille, France

CHRU Dupuytren; 🇫🇷 Limoges, France

Hôpital de la Timone; 🇫🇷 Marseille, France

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