Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT01517594
Status:
COMPLETED
Last Update Posted:
2013-10-21
First Post:
2012-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 568}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-18', 'studyFirstSubmitDate': '2012-01-20', 'studyFirstSubmitQcDate': '2012-01-20', 'lastUpdatePostDateStruct': {'date': '2013-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'verify the safety profile: measured by number of AEs/SAEs', 'timeFrame': '12 months from patient recruitment'}], 'secondaryOutcomes': [{'measure': 'dosage: evaluate dosage level', 'timeFrame': '12 months from patient recruitment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'Confirmation of safety profile'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* treatment of Ulcerative Colitis\n\nExclusion Criteria:\n\n* hypersensitivity to mesalazine\n* severe liver or renal impairment'}, 'identificationModule': {'nctId': 'NCT01517594', 'briefTitle': 'Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic', 'orgStudyIdInfo': {'id': '000026'}}, 'contactsLocationsModule': {'locations': [{'city': 'Brno', 'country': 'Czechia', 'facility': 'FN sv.Anna', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Gastroenterologická ambulance', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Hospital Milosrdných bratří', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Břeclav', 'country': 'Czechia', 'facility': 'Hospital Břeclav', 'geoPoint': {'lat': 48.75897, 'lon': 16.88203}}, {'city': 'Cheb', 'country': 'Czechia', 'facility': 'Nemocnice Cheb', 'geoPoint': {'lat': 50.07963, 'lon': 12.37392}}, {'city': 'Fryštát', 'country': 'Czechia', 'facility': 'Nemocnice s poliklinikou Ráj', 'geoPoint': {'lat': 49.854, 'lon': 18.54169}}, {'city': 'Hodonín', 'country': 'Czechia', 'facility': 'Gastroenterologická ambulance Hodonín', 'geoPoint': {'lat': 48.84893, 'lon': 17.13244}}, {'city': 'Hodonín', 'country': 'Czechia', 'facility': 'Hospital TGM Hodonín', 'geoPoint': {'lat': 48.84893, 'lon': 17.13244}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'FN, II. Interní klinika', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Jičín', 'country': 'Czechia', 'facility': 'Oblastní nemoncice Jičín', 'geoPoint': {'lat': 50.43723, 'lon': 15.35162}}, {'city': 'Karlovy Vary', 'country': 'Czechia', 'facility': 'Nemocnice Karlovy Vary', 'geoPoint': {'lat': 50.23271, 'lon': 12.87117}}, {'city': 'Litoměřice', 'country': 'Czechia', 'facility': 'Gastroenterologická ambulance Jezuitská', 'geoPoint': {'lat': 50.53348, 'lon': 14.1318}}, {'city': 'Litoměřice', 'country': 'Czechia', 'facility': 'Gastroenterologická ambulance Litoměřice', 'geoPoint': {'lat': 50.53348, 'lon': 14.1318}}, {'city': 'Ostrava', 'country': 'Czechia', 'facility': 'GASTRO MED, s.r.o.', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Gastromedic s.r.o.', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'city': 'Pilsen', 'country': 'Czechia', 'facility': '4. poliklinika Plzeň, Gastroenterologická ambulance', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Fakultní poliklinika VFN', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'FN Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Iscare', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Poliklinika - gastroenterologie', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Poliklinika Clinicum - Interna', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Sanatorium sv. Anny', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Ústřední vojenská nemocnice', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prostějov', 'country': 'Czechia', 'facility': 'Hospital Prostějov', 'geoPoint': {'lat': 49.47188, 'lon': 17.11184}}, {'city': 'Přerov', 'country': 'Czechia', 'facility': 'Poliklinika Mens', 'geoPoint': {'lat': 49.45511, 'lon': 17.4509}}, {'city': 'Rychnov nad Kněžnou', 'country': 'Czechia', 'facility': 'Poliklinika - gastroenterologie Rychnov nad Kněžnou', 'geoPoint': {'lat': 50.16284, 'lon': 16.27488}}, {'city': 'Ústí nad Labem', 'country': 'Czechia', 'facility': 'Masarykova nemocnice,Interna', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'city': 'Valašské Meziříčí', 'country': 'Czechia', 'facility': 'Nemocnice Valašské Meziříčí', 'geoPoint': {'lat': 49.47181, 'lon': 17.97113}}, {'city': 'Vítkovice', 'country': 'Czechia', 'facility': 'Vítkovická nemocnice', 'geoPoint': {'lat': 50.67902, 'lon': 15.5312}}, {'city': 'Zlín', 'country': 'Czechia', 'facility': 'Krajská nemocnice T.Bati', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}