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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451360
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : July 25, 2008
Information provided by:
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

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Drug: diacerein Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.
Study Start Date : March 1993
Actual Study Completion Date : April 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Primary Outcome Measures :
  1. Joint space measurement

Secondary Outcome Measures :
  1. Requirement of hip replacement surgery after ten years
  2. Tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00451360

Hôpital Nord
Amiens, France, 80030
Hôpital Pellegrin
Bordeaux, France, 33076
Hôpital Ambroise Paré
Boulogne, France, 92100
CHU cote de Nacre
Caen, France, 14033
Hôpital Mondor
Créteil, France, 94000
Hôpital Général
Dijon, France, 21000
Grenoble, France, 38043
Hôpital Roger Salengro
Lille, France, 59037
CHRU Dupuytren
Limoges, France, 87042
Hôpital de la Timone
Marseille, France, 13 385
Hôpital Lapeyronie
Montpellier, France, 34295
Hôpital de l'Archet
Nice, France, 6202
Hôpital Cochin, clinique de rhumatologie
Paris, France, 74014
Paris, France, 75011
Hôpital Cochin
Paris, France, 75014
Hôpital Leopold Bellan
Paris, France, 75674
CH Lyon Sud
Pierre Bénite, France, 69495
CHU Lyon Sud
Pierre Bénite, France, 69495
Hôpital de la Milétrie
Poitiers, France, 86 021
Rennes, France, 35000
Hôpitam de Bois Guillaume
Rouen, France, 76031
Hôpital de Hautepierre
Strasbourg, France, 67098
CHU de Rangueil
Toulouse, France, 31403
CHU Trousseau
Tours, France, 37044
CHU de Brabois
Vandoeuvre les Nancy, France, 54511
Sponsors and Collaborators
Laboratoires NEGMA
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 of Results: Identifier: NCT00451360     History of Changes
Other Study ID Numbers: HEC / CHO 90040N
AFSSAPS number: 930289
CCPPRB number: 469
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: July 25, 2008
Last Verified: March 2007

Keywords provided by Laboratoires NEGMA:
Hip osteoarthritis
Structure-modifying effect / Chondromodulating effect
Double blind study

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents