Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip

Hip Osteoarthritis Clinical Trial

— ECHODIAH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451360
• Other study ID #: HEC / CHO 90040N
• Secondary ID: AFSSAPS number:
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2007
• Last updated: July 24, 2008
• Start date: March 1993
• Est. completion date: April 1997

Study information

• Verified date: March 2007
• Source: Laboratoires NEGMA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: April 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Drug:
• diacerein

Locations

Country	Name	City	State
France	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	Hôpital Lapeyronie	Montpellier
France	Hôpital de l'Archet	Nice
France	Hôpital Cochin	Paris
France	Hôpital Cochin, clinique de rhumatologie	Paris
France	Hôpital Leopold Bellan	Paris
France	CH Lyon Sud	Pierre Bénite
France	CHU Lyon Sud	Pierre Bénite
France	Hôpital de la Milétrie	Poitiers
France	CHR	Rennes
France	Hôpitam de Bois Guillaume	Rouen
France	Hôpital de Hautepierre	Strasbourg
France	CHU de Rangueil	Toulouse
France	CHU Trousseau	Tours
France	CHU de Brabois	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires NEGMA

Country where clinical trial is conducted

France, 

References & Publications (1)

Dougados M, Nguyen M, Berdah L, Maziéres B, Vignon E, Lequesne M; ECHODIAH Investigators Study Group. Evaluation of the structure-modifying effects of diacerein in hip osteoarthritis: ECHODIAH, a three-year, placebo-controlled trial. Evaluation of the Cho — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint space measurement
Secondary	Requirement of hip replacement surgery after ten years
Secondary	Tolerability