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

This study has been completed.
Sponsor:
Information provided by:
Laboratoires NEGMA
ClinicalTrials.gov Identifier:
NCT00451360
First received: March 22, 2007
Last updated: July 24, 2008
Last verified: March 2007
  Purpose

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 Intervention Phase
Hip Osteoarthritis
Drug: diacerein
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.

Resource links provided by NLM:


Further study details as provided by Laboratoires NEGMA:

Primary Outcome Measures:
  • Joint space measurement

Secondary Outcome Measures:
  • Requirement of hip replacement surgery after ten years
  • Tolerability

Estimated Enrollment: 500
Study Start Date: March 1993
Study Completion Date: April 1997
  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451360

Locations
France
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
CHU
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 Leopold Bellan
Paris, France, 75674
Hôpital Cochin
Paris, France, 75014
Hôpital Cochin, clinique de rhumatologie
Paris, France, 74014
Paris, France, 75011
CH Lyon Sud
Pierre Bénite, France, 69495
CHU Lyon Sud
Pierre Bénite, France, 69495
Hôpital de la Milétrie
Poitiers, France, 86 021
CHR
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
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00451360     History of Changes
Other Study ID Numbers: HEC / CHO 90040N, AFSSAPS number: 930289, CCPPRB number: 469
Study First Received: March 22, 2007
Last Updated: July 24, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diacetylrhein
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014