Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip (ECHODIAH)
This study has been completed.
Sponsor:
Laboratoires NEGMA
Information provided by:
Laboratoires NEGMA
ClinicalTrials.gov Identifier:
NCT00451360
First received: March 22, 2007
Last updated: July 24, 2008
Last verified: March 2007
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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:
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
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 Cochin, clinique de rhumatologie | |
| Paris, France, 74014 | |
| Hôpital Cochin | |
| Paris, France, 75014 | |
| Paris, France, 75011 | |
| Hôpital Leopold Bellan | |
| Paris, France, 75674 | |
| 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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013