Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip (ECHODIAH)

July 24, 2008 updated by: Laboratoires NEGMA

Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80030
        • Hôpital Nord
      • Bordeaux, France, 33076
        • Hôpital Pellegrin
      • Boulogne, France, 92100
        • Hôpital Ambroise Paré
      • Caen, France, 14033
        • CHU côte de Nacre
      • Créteil, France, 94000
        • Hopital Mondor
      • Dijon, France, 21000
        • Hôpital Général
      • Grenoble, France, 38043
        • CHU
      • Lille, France, 59037
        • Hopital Roger Salengro
      • Limoges, France, 87042
        • CHRU Dupuytren
      • Marseille, France, 13 385
        • hopital de la Timone
      • Montpellier, France, 34295
        • Hopital Lapeyronie
      • Nice, France, 6202
        • Hôpital de l'Archet
      • Paris, France, 75014
        • Hôpital Cochin
      • Paris, France, 75011
      • Paris, France, 75674
        • Hôpital Léopold BELLAN
      • Paris, France, 74014
        • Hôpital Cochin, clinique de rhumatologie
      • Pierre Bénite, France, 69495
        • CHU Lyon Sud
      • Pierre Bénite, France, 69495
        • CH Lyon sud
      • Poitiers, France, 86 021
        • Hopital de la Milétrie
      • Rennes, France, 35000
        • CHR
      • Rouen, France, 76031
        • Hôpitam de Bois Guillaume
      • Strasbourg, France, 67098
        • Hôpital de Hautepierre
      • Toulouse, France, 31403
        • CHU de Rangueil
      • Tours, France, 37044
        • CHU Trousseau
      • Vandoeuvre les Nancy, France, 54511
        • CHU de Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Joint space measurement

Secondary Outcome Measures

Outcome Measure
Tolerability
Requirement of hip replacement surgery after ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires NEGMA

Investigators

  • Principal Investigator: DOUGADOS Maxime, Scientific Committee
  • Principal Investigator: Michel LEQUESNE, Scientific Committee
  • Principal Investigator: Bernard MAZIERE, Scientific Committee
  • Principal Investigator: Eric VIGNON, Scientific Committee
  • Principal Investigator: Laurent BERDAH, Scientific Committee
  • Principal Investigator: Minh NGUYEN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1993

Study Completion (ACTUAL)

April 1, 1997

Study Registration Dates

First Submitted

March 22, 2007

First Submitted That Met QC Criteria

March 22, 2007

First Posted (ESTIMATE)

March 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2008

Last Update Submitted That Met QC Criteria

July 24, 2008

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEC / CHO 90040N
  • AFSSAPS number: 930289
  • CCPPRB number: 469

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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