Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-21 @ 5:12 AM
Study NCT ID:
NCT02142634
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2014-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Budesonide for Induction of Remission in Incomplete Microscopic Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2014-05-14', 'studyFirstSubmitQcDate': '2014-05-16', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of clinical remission', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Rate of clinical remission', 'timeFrame': '2 weeks'}, {'measure': 'Rate of clinical remission', 'timeFrame': '6 weeks'}, {'measure': 'Time to remission', 'timeFrame': '8 weeks'}, {'measure': 'Number of formed/soft/watery stools per week', 'timeFrame': '8 weeks'}, {'measure': 'Number of days with abdominal pain', 'timeFrame': '8 weeks'}, {'measure': 'Number of days with urgency', 'timeFrame': '8 weeks'}, {'measure': 'Rate of histological remission', 'timeFrame': '8 weeks'}, {'measure': "Physician's global assessment at final visit", 'timeFrame': '8 weeks'}, {'measure': 'Quality of life', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Incomplete Microscopic Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically established diagnosis of incomplete microscopic colitis (MCi)\n* History of chronic non-bloody, watery diarrhoea\n* Clinically active disease\n\nExclusion Criteria:\n\n* Other significant abnormalities in colonoscopy\n* Infectious cause of diarrhoea\n* Clinical suspicion of drug-induced diarrhoea\n* Prior and present MC\n* History of bowel resection\n* Radiation therapy of the abdominal or pelvic region\n* Positive antibody titres for celiac disease\n* Untreated active thyroid dysfunction\n* Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy\n* Abnormal hepatic function\n* Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured\n* History of colorectal cancer\n* History of cancer (other than colorectal) in the last 5 years\n* Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs\n* Current or intended pregnancy or breast-feeding\n* Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs\n* Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial"}, 'identificationModule': {'nctId': 'NCT02142634', 'briefTitle': 'Budesonide for Induction of Remission in Incomplete Microscopic Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Falk Pharma GmbH'}, 'officialTitle': 'Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis', 'orgStudyIdInfo': {'id': 'BUG-3/MIC'}, 'secondaryIdInfos': [{'id': '2013-001912-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Budesonide granules 9 mg', 'interventionNames': ['Drug: Budesonide granules 9 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo granules', 'interventionNames': ['Drug: Placebo granules']}], 'interventions': [{'name': 'Budesonide granules 9 mg', 'type': 'DRUG', 'description': 'per day', 'armGroupLabels': ['A']}, {'name': 'Placebo granules', 'type': 'DRUG', 'description': 'per day', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20249', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Centre for Digestive Diseases', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'University Hospital of Linköping, Dept. of Gastroenterology and Hepatology', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Andreas Münch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Linköping, Dept. of Gastroenterology and Hepatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Falk Pharma GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}