Clinical trial NCT00451360: Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip
Official title: Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Osteoarthritis
Keywords: Diacerein
Hip osteoarthritis
Structure-modifying effect / Chondromodulating effect
Double blind study
Lead sponsor: Laboratoires NEGMA
Sponsor class: INDUSTRY
First posted: 2007-03-23
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Joint space measurement
Secondary outcomes:
measure: Requirement of hip replacement surgery after ten years
measure: Tolerability
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hôpital Nord
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Boulogne
country: France
facility: Hôpital Ambroise Paré
city: Caen
country: France
facility: CHU cote de Nacre
city: Créteil
country: France
facility: Hôpital Mondor
city: Dijon
country: France
facility: Hôpital Général
city: Grenoble
country: France
facility: CHU
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Limoges
country: France
facility: CHRU Dupuytren
city: Marseille
country: France
facility: Hôpital de la Timone
city: Montpellier
country: France
facility: Hôpital Lapeyronie
city: Nice
country: France
facility: Hôpital de l'Archet
city: Paris
country: France
facility: Hôpital Cochin, clinique de rhumatologie
city: Paris
country: France
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Leopold Bellan
city: Pierre Bénite
country: France
facility: CH Lyon Sud
city: Pierre Bénite
country: France
facility: CHU Lyon Sud
city: Poitiers
country: France
facility: Hôpital de la Milétrie
city: Rennes
country: France
facility: CHR
city: Rouen
country: France
facility: Hôpitam de Bois Guillaume
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Toulouse
country: France
facility: CHU de Rangueil
city: Tours
country: France
facility: CHU Trousseau
city: Vandoeuvre les Nancy
country: France
facility: CHU de Brabois
Study officials:
affiliation: Scientific committee
name: DOUGADOS Maxime
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific committee
name: Michel LEQUESNE
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific committee
name: Bernard MAZIERE
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific committee
name: Eric VIGNON
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific committee
name: Laurent BERDAH
role: PRINCIPAL_INVESTIGATOR
name: Minh NGUYEN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dougados M, Nguyen M, Berdah L, Mazieres 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 Chondromodulating Effect of Diacerein in OA of the Hip. Arthritis Rheum. 2001 Nov;44(11):2539-47. doi: 10.1002/1529-0131(200111)44:113.0.co;2-t.