Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2026-01-02 @ 7:23 AM
Study NCT ID:
NCT00035503
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2002-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Trial For Patients With Acute Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C450000', 'term': 'etiprednol dicloacetate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2004-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2002-05-03', 'studyFirstSubmitQcDate': '2002-05-03', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2002-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01-31', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to see if etiprednol dicloacetate is safe and effective for the treatment of acute Crohn's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* Must have active confirmed Crohn's disease with CDAI \\> 220 and \\< 400.\n* Otherwise healthy."}, 'identificationModule': {'nctId': 'NCT00035503', 'briefTitle': "Multicenter Trial For Patients With Acute Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'orgStudyIdInfo': {'id': 'IXR-201-19-166'}}, 'armsInterventionsModule': {'interventions': [{'name': 'etiprednol dicloacetate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stuart Weisman', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Mark Lamet', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Wayne Schonfeld', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Hospital Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Gerald Dryden', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Richard MacDermott', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': 'M5G 1XB', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hillary Steinhart', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Gary Wild', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}