NCT00451360

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 1993

Typical duration for phase_3

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1993

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1997

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
Last Updated

July 25, 2008

Status Verified

March 1, 2007

First QC Date

March 22, 2007

Last Update Submit

July 24, 2008

Conditions

Hip Osteoarthritis

Keywords

DiacereinHip osteoarthritisStructure-modifying effect / Chondromodulating effectDouble blind study

Outcome Measures

Primary Outcomes (1)

  • Joint space measurement

Secondary Outcomes (2)

  • Requirement of hip replacement surgery after ten years

  • Tolerability

Interventions

diacereinDRUG

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients fulfilling the American College of Rheumatology criteria for the diagnosis of hip osteoarthritis.
  • Lequesne algofunctional index of at list 3 points.

You may not qualify if:

  • Any systemic or intraarticular corticosteroid as well as other potential symptom-modifying drugs for osteoarthritis were not allowed during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Hôpital Nord

Amiens, 80030, France

Location

Hôpital Pellegrin

Bordeaux, 33076, France

Location

Hôpital Ambroise Paré

Boulogne, 92100, France

Location

CHU cote de Nacre

Caen, 14033, France

Location

Hôpital Mondor

Créteil, 94000, France

Location

Hôpital Général

Dijon, 21000, France

Location

CHU

Grenoble, 38043, France

Location

Hôpital Roger Salengro

Lille, 59037, France

Location

CHRU Dupuytren

Limoges, 87042, France

Location

Hôpital de la Timone

Marseille, 13 385, France

Location

Hôpital Lapeyronie

Montpellier, 34295, France

Location

Hôpital de l'Archet

Nice, 6202, France

Location

Hôpital Cochin, clinique de rhumatologie

Paris, 74014, France

Location

Unknown Facility

Paris, 75011, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Leopold Bellan

Paris, 75674, France

Location

CH Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Lyon Sud

Pierre-Bénite, 69495, France

Location

Hôpital de la Milétrie

Poitiers, 86 021, France

Location

CHR

Rennes, 35000, France

Location

Hôpitam de Bois Guillaume

Rouen, 76031, France

Location

Hôpital de Hautepierre

Strasbourg, 67098, France

Location

CHU de Rangueil

Toulouse, 31403, France

Location

CHU Trousseau

Tours, 37044, France

Location

CHU de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • 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.

    PMID: 11710710RESULT

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

diacerein

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 22, 2007

First Posted

March 23, 2007

Study Start

March 1, 1993

Study Completion

April 1, 1997

Last Updated

July 25, 2008

Record last verified: 2007-03

Locations

FR(25)