Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-31 @ 8:14 PM
Study NCT ID:
NCT00209300
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ulcerative Colitis for Maintenance of Remission'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months.\n\nEndoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months).\n\nNumber of Subjects (Planned and Analysed):\n\n* 360 patients for demonstration of non-inferiority between once daily and twice daily;\n* 326 to be analysed in per-protocol (PP) analyses; and\n* 360 in intention-to-treat (ITT) analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients have an established diagnosis of ulcerative colitis and are in clinical remission with an UC-DAI \\< 2 at enrollment\n2. Extension of the disease \\> 15 cm distance from anal verge\n3. Patients who have had a clinical relapse within the past year. Clinical relapse is defined as activity of the disease for which maintenance therapy had to be adjusted.\n4. Patients on oral mesalazine maintenance therapy ≤ 2.5 grams per day\n5. 18 years or older\n6. Signed informed consent\n\nExclusion Criteria:\n\n1. Patients with evidence of other forms of inflammatory bowel disease, idiopathic proctitis or infectious disease\n2. Patients allergic to acetylsalicylic acid and other salicylate derivates aspirin or salicylates derivatives\n3. Patients who used mesalazine \\> 2.5 grams orally in the previous month,\n4. Patients who used rectal mesalazine \\> 3 grams per week in the previous month\n5. Use of corticosteroids (oral and/or rectal routes) within the last month\n6. Intake of immunosuppressants within the last 3 months\n7. Patients with (known) significant hepatic (up to 2 x upper limit of normal) or (known) renal function abnormalities, to 1.5 x upper limit of normal values\n8. Patients with history or physical examination findings indicative of active alcohol or drug abuse\n9. Patients with a history of disease, including mental/emotional disorders, that would interfere with their participation in the study\n10. Women who are pregnant or nursing (non-menopausal women who are sexually active and do not use effective contraceptives, as judged by the investigator, must have a negative pregnancy test)\n11. Patients who participated in another clinical study in the last 3 months\n12. Patients who were previously participating in this study\n13. Patients with any other disease that may influence the study assessment, such as malignant disease, etc.\n14. Patients who are unable to comply with any requirements of the protocol\n15. Patients who are unable to write or read local language.'}, 'identificationModule': {'nctId': 'NCT00209300', 'briefTitle': 'Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily', 'orgStudyIdInfo': {'id': 'FE999907 CS003'}, 'secondaryIdInfos': [{'id': '2004-004565-15'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Pentasa', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'UMC Sint-Pieter', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'B-4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHR de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'B-8800', 'city': 'Roeselaere', 'country': 'Belgium', 'facility': 'Heilig Hart Ziekenhuis'}, {'zip': 'B-2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'AZ St. Augustinus', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '390 03', 'city': 'Jaroše', 'country': 'Czechia', 'facility': 'Internal department Hospital Tábor'}, {'zip': '506 43', 'city': 'Jičín', 'country': 'Czechia', 'facility': 'Internal department, Hospital Jičín', 'geoPoint': {'lat': 50.43723, 'lon': 15.35162}}, {'zip': '430 12', 'city': 'Kochova', 'country': 'Czechia', 'facility': 'Internal department Hospital Chomutov'}, {'zip': '293 50', 'city': 'Mladá Boleslav', 'country': 'Czechia', 'facility': 'Hospital Mladá Boleslav - Internal Department', 'geoPoint': {'lat': 50.41135, 'lon': 14.90318}}, {'zip': '290 01', 'city': 'Poděbrady', 'country': 'Czechia', 'facility': 'Gastroenterologie MUDr.V.Abrahámová', 'geoPoint': {'lat': 50.14242, 'lon': 15.11881}}, {'zip': '101 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Internal department, Hospital of Merciful sisters', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '120 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Gastroenterological Centre, University Hospital of Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '130 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'EGK s.r.o, Gastroenterology', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '180 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Internal department University Hospital Na Bulovce', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '261 95', 'city': 'Příbram', 'country': 'Czechia', 'facility': 'Internal department Hospital', 'geoPoint': {'lat': 49.68988, 'lon': 14.01043}}, {'zip': '2300', 'city': 'Copenhagen S', 'country': 'Denmark', 'facility': 'Amager Hospital Medicinsk Center'}, {'zip': '3000', 'city': 'Elsinore', 'country': 'Denmark', 'facility': 'Helsingor Sygehus', 'geoPoint': {'lat': 56.03606, 'lon': 12.6136}}, {'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Amtsygehuset i Gentofte', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '9800', 'city': 'Hjørring', 'country': 'Denmark', 'facility': 'Sygehus Vendsyssel', 'geoPoint': {'lat': 57.46417, 'lon': 9.98229}}, {'zip': '4700', 'city': 'Næstved', 'country': 'Denmark', 'facility': 'Naestved Sygehys', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'zip': '6400', 'city': 'Sønderborg', 'country': 'Denmark', 'facility': 'Sonderborg Sygehus', 'geoPoint': {'lat': 54.90896, 'lon': 9.78917}}, {'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Vejle Sygehus', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Viborg Sygehus', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}, {'zip': '80210', 'city': 'Joensuu', 'country': 'Finland', 'facility': 'North Karelia Central Hospital', 'geoPoint': {'lat': 62.60118, 'lon': 29.76316}}, {'zip': '86150', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dres. 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