Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip

NCT ID: NCT00451360

Last Updated: 2008-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-03-31

Study Completion Date

1997-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Osteoarthritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diacerein Hip osteoarthritis Structure-modifying effect / Chondromodulating effect Double blind study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

diacerein

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laboratoires NEGMA

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

DOUGADOS Maxime

Role: PRINCIPAL_INVESTIGATOR

Scientific committee

Michel LEQUESNE

Role: PRINCIPAL_INVESTIGATOR

Scientific committee

Bernard MAZIERE

Role: PRINCIPAL_INVESTIGATOR

Scientific committee

Eric VIGNON

Role: PRINCIPAL_INVESTIGATOR

Scientific committee

Laurent BERDAH

Role: PRINCIPAL_INVESTIGATOR

Scientific committee

Minh NGUYEN

Role: PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Nord

Amiens, , France

Site Status

Hôpital Pellegrin

Bordeaux, , France

Site Status

Hôpital Ambroise Paré

Boulogne, , France

Site Status

CHU cote de Nacre

Caen, , France

Site Status

Hôpital Mondor

Créteil, , France

Site Status

Hôpital Général

Dijon, , France

Site Status

CHU

Grenoble, , France

Site Status

Hôpital Roger Salengro

Lille, , France

Site Status

CHRU Dupuytren

Limoges, , France

Site Status

Hôpital de la Timone

Marseille, , France

Site Status

Hôpital Lapeyronie

Montpellier, , France

Site Status

Hôpital de l'Archet

Nice, , France

Site Status

Hôpital Cochin, clinique de rhumatologie

Paris, , France

Site Status

Paris, , France

Site Status

Hôpital Cochin

Paris, , France

Site Status

Hôpital Leopold Bellan

Paris, , France

Site Status

CH Lyon Sud

Pierre-Bénite, , France

Site Status

CHU Lyon Sud

Pierre-Bénite, , France

Site Status

Hôpital de la Milétrie

Poitiers, , France

Site Status

CHR

Rennes, , France

Site Status

Hôpitam de Bois Guillaume

Rouen, , France

Site Status

Hôpital de Hautepierre

Strasbourg, , France

Site Status

CHU de Rangueil

Toulouse, , France

Site Status

CHU Trousseau

Tours, , France

Site Status

CHU de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 11710710 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AFSSAPS number: 930289

Identifier Type: -

Identifier Source: secondary_id

CCPPRB number: 469

Identifier Type: -

Identifier Source: secondary_id

HEC / CHO 90040N

Identifier Type: -

Identifier Source: org_study_id