Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-27 @ 3:51 PM
Study NCT ID:
NCT02550418
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2015-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Budesonide 9 mg Capsules in Active UC
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': 'D019819', 'term': 'Budesonide'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2015-09-14', 'studyFirstSubmitQcDate': '2015-09-14', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of clinical remission at final/withdrawal visit', 'timeFrame': '8 weeks treatment', 'description': 'Clinical remission includes normalisation of stool frequency and absence of blood in stools'}], 'secondaryOutcomes': [{'measure': 'Rate of endoscopic remission/improvement at final/withdrawal visit', 'timeFrame': '8 weeks treatment'}, {'measure': 'Number of stools / bloody stools per week', 'timeFrame': '8 weeks treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colitis, Ulcerative']}, 'referencesModule': {'references': [{'pmid': '33028169', 'type': 'DERIVED', 'citation': 'Fellermann K, Schiefke I, Racz I, Derova J, Jonaitis L, Wehrum S, Nacak T, Greinwald R. Efficacy and safety of prolonged release budesonide granules in mesalazine-refractory ulcerative colitis: A multi-centre Phase IIa study (TOPICAL-1). United European Gastroenterol J. 2020 Dec;8(10):1186-1195. doi: 10.1177/2050640620962632. Epub 2020 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent,\n* Men or women aged 18 to 75 years,\n* Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,\n* Established disease,\n\nExclusion Criteria:\n\n* Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,\n* Toxic megacolon or fulminant colitis,\n* Colon resection,\n* Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),\n* Malabsorption syndromes,\n* Celiac disease,\n* Bleeding hemorrhoids,\n* Active peptic ulcer disease\n* Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,\n* Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,\n* Any severe infectious disease (e.g., tuberculosis, AIDS),\n* Severe co-morbidity substantially reducing life expectancy,\n* History of colorectal cancer,\n* History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma"}, 'identificationModule': {'nctId': 'NCT02550418', 'acronym': 'TOPICAL-1', 'briefTitle': 'Budesonide 9 mg Capsules in Active UC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Falk Pharma GmbH'}, 'officialTitle': 'Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'BUX-3/UCA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Budesonide', 'interventionNames': ['Drug: Budesonide']}], 'interventions': [{'name': 'Budesonide', 'type': 'DRUG', 'armGroupLabels': ['Budesonide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'University of Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Klaus Fellermann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Schleswig-Holstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Falk Pharma GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}