Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT02493335
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2015-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'C494814', 'term': 'BID protein, human'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2015-07-07', 'studyFirstSubmitQcDate': '2015-07-07', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients free of treatment failure after 48 weeks of treatment.', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'Rate of patients with histological relapse', 'timeFrame': '48 weeks'}, {'measure': 'Rate of patients with clinical relapse', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Eosinophilic Esophagitis']}, 'referencesModule': {'references': [{'pmid': '39694205', 'type': 'DERIVED', 'citation': 'Biedermann L, Schlag C, Straumann A, Lucendo AJ, Miehlke S, Vieth M, Santander C, Ciriza de Los Rios C, Schmocker C, Madisch A, Hruz P, Hayat J, von Arnim U, Bredenoord AJ, Schubert S, Halstead M, Pfurr S, Mueller R, Schoepfer AM, Attwood S; International EOS-2 Study Group. Efficacy and Safety of Budesonide Orodispersible Tablets for Eosinophilic Esophagitis up to 3 Years: An Open-Label Extension Study. Clin Gastroenterol Hepatol. 2025 Nov;23(12):2144-2154.e6. doi: 10.1016/j.cgh.2024.10.034. Epub 2024 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent,\n* Male or female patients, 18 to 75 years of age,\n* Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria\n* Clinico-pathological remission of EoE,\n* A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia,\n* Negative pregnancy test in females of childbearing potential at baseline visit.\n\nExclusion Criteria:\n\n* Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),\n* History of abnormal results in case of an optionally performed pH-monitoring of the distal esophagus,\n* Patients with PPI-responsive esophageal eosinophilia\n* Achalasia, scleroderma esophagus, or systemic sclerosis,\n* Other clinically evident causes than EoE for esophageal eosinophilia,\n* Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \\[candida esophagitis\\]),\n* Any relevant systemic disease (e.g., AIDS, active tuberculosis),\n* If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,\n* Liver cirrhosis or portal hypertension,\n* History of cancer in the last five years,\n* History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit,\n* Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,\n* Existing or intended pregnancy or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT02493335', 'acronym': 'EOS-2', 'briefTitle': 'Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Falk Pharma GmbH'}, 'officialTitle': 'Double-blind, Randomized, Placebo-controlled, Phase III Study on the Efficacy and Tolerability of a 48-week Treatment With Two Different Doses of Budesonide Effervescent Tablets vs. Placebo for Maintenance of Clinico-pathological Remission in Adult Patients With Eosinophilic Esophagitis', 'orgStudyIdInfo': {'id': 'BUL-2/EER'}, 'secondaryIdInfos': [{'id': '2014-001485-99', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Budesonide 0.5mg orodispersible tablet twice daily', 'description': 'Budesonide 0.5mg orodispersible tablet twice daily', 'interventionNames': ['Drug: Budesonide 0.5mg orodispersible tablet twice daily']}, {'type': 'EXPERIMENTAL', 'label': 'Budesonide 1mg orodispersible tablet twice daily', 'description': 'Budesonide 1mg orodispersible tablet twice daily', 'interventionNames': ['Drug: Budesonide 1mg orodispersible tablet twice daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo orodispersible tablet twice daily', 'description': 'Placebo orodispersible tablet twice daily', 'interventionNames': ['Drug: Placebo orodispersible tablet twice daily']}], 'interventions': [{'name': 'Budesonide 0.5mg orodispersible tablet twice daily', 'type': 'DRUG', 'otherNames': ['BUL 0.5mg BID'], 'armGroupLabels': ['Budesonide 0.5mg orodispersible tablet twice daily']}, {'name': 'Budesonide 1mg orodispersible tablet twice daily', 'type': 'DRUG', 'otherNames': ['BUL 1mg BID'], 'armGroupLabels': ['Budesonide 1mg orodispersible tablet twice daily']}, {'name': 'Placebo orodispersible tablet twice daily', 'type': 'DRUG', 'otherNames': ['Placebo BID'], 'armGroupLabels': ['Placebo orodispersible tablet twice daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20249', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Center for Digestive Diseases Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Ralph Mueller, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dr. Falk Pharma GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Falk Pharma GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}