Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-30 @ 10:12 AM
Study NCT ID:
NCT00451360
Status:
COMPLETED
Last Update Posted:
2008-07-25
First Post:
2007-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C025292', 'term': 'diacerein'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '1997-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-24', 'studyFirstSubmitDate': '2007-03-22', 'studyFirstSubmitQcDate': '2007-03-22', 'lastUpdatePostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Joint space measurement'}], 'secondaryOutcomes': [{'measure': 'Requirement of hip replacement surgery after ten years'}, {'measure': 'Tolerability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diacerein', 'Hip osteoarthritis', 'Structure-modifying effect / Chondromodulating effect', 'Double blind study'], 'conditions': ['Hip Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '11710710', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to:\n\n* evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis\n* to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis\n\nThis study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients fulfilling the American College of Rheumatology criteria for the diagnosis of hip osteoarthritis.\n* Lequesne algofunctional index of at list 3 points.\n* 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.\n\nExclusion Criteria:\n\n* Intraarticular injection or arthroscopy of the hip during the three months prior to inclusion in the study.\n* Any systemic or intraarticular corticosteroid as well as other potential symptom-modifying drugs for osteoarthritis were not allowed during the study.'}, 'identificationModule': {'nctId': 'NCT00451360', 'acronym': 'ECHODIAH', 'briefTitle': 'Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires NEGMA'}, 'officialTitle': 'Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.', 'orgStudyIdInfo': {'id': 'HEC / CHO 90040N'}, 'secondaryIdInfos': [{'id': 'AFSSAPS number: 930289'}, {'id': 'CCPPRB number: 469'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'diacerein', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80030', 'city': 'Amiens', 'country': 'France', 'facility': 'Hôpital Nord', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92100', 'city': 'Boulogne', 'country': 'France', 'facility': 'Hôpital Ambroise Paré', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU cote de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Hôpital Général', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHRU Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13 385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '6202', 'city': 'Nice', 'country': 'France', 'facility': "Hôpital de l'Archet", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '74014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin, clinique de rhumatologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75011', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75674', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Leopold Bellan', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'CH Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'CHU Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86 021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Hôpital de la Milétrie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'CHR', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Hôpitam de Bois Guillaume', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31403', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Trousseau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'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', 'affiliation': 'Scientific committee'}, {'name': 'Minh NGUYEN', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires NEGMA', 'class': 'INDUSTRY'}}}}