Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2026-02-27 @ 10:37 AM
Study NCT ID:
NCT02280616
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2014-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension 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': 'C462501', 'term': 'DNER protein, human'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-20', 'studyFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of histological remission', 'timeFrame': '2 weeks (LOCF)'}, {'measure': 'Change in the mean numbers of eos', 'timeFrame': '2 weeks (LOCF)'}], 'secondaryOutcomes': [{'measure': 'Change in the mean numbers of eos', 'timeFrame': '2 weeks (LOCF)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Eosinophilic Esophagitis']}, 'referencesModule': {'references': [{'pmid': '25792708', 'type': 'RESULT', 'citation': 'Miehlke S, Hruz P, Vieth M, Bussmann C, von Arnim U, Bajbouj M, Schlag C, Madisch A, Fibbe C, Wittenburg H, Allescher HD, Reinshagen M, Schubert S, Tack J, Muller M, Krummenerl P, Arts J, Mueller R, Dilger K, Greinwald R, Straumann A. A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis. Gut. 2016 Mar;65(3):390-9. doi: 10.1136/gutjnl-2014-308815. Epub 2015 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n* Signed informed consent\n* Male or female patients, 18 to 75 years of age\n* Confirmed clinicopathological diagnosis of EoE according to established diagnostic criteria:\n\n(A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1 high-power field (hpf)\n\n\\- Active symptomatic and histological EoE at baseline\n\nMajor Exclusion Criteria:\n\n* Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia\n* Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia\n* Other clinical 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)\n* Any relevant systemic disease (e.g., AIDS, active tuberculosis)\n* Abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension\n* Abnormal renal function at screening\n* History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma)\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 screening visit\n* Concomitant, or within the 4 weeks prior to screening visit, treatment with systemic therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants\n* Concomitant, or within the 2 weeks prior to screening visit, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate\n* Installation of dietary restrictions within 4 weeks prior to screening visit or during treatment\n* Intake of grapefruit containing food or beverages during the treatment with study medication\n* Known intolerance/hypersensitivity to study drug\n* Existing or intended pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT02280616', 'briefTitle': 'Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Falk Pharma GmbH'}, 'officialTitle': 'Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic Esophagitis', 'orgStudyIdInfo': {'id': 'BUU-2/EEA'}, 'secondaryIdInfos': [{'id': '2009-016692-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose budesonide tablet', 'interventionNames': ['Drug: low dose budesonide tablet']}, {'type': 'EXPERIMENTAL', 'label': 'High dose budesonide tablet', 'interventionNames': ['Drug: high dose budesonide tablet']}, {'type': 'EXPERIMENTAL', 'label': 'High dose budesonide suspension', 'interventionNames': ['Drug: high dose budesonide suspension']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'low dose budesonide tablet', 'type': 'DRUG', 'otherNames': ['BET 1mg BID'], 'description': '1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily', 'armGroupLabels': ['Low dose budesonide tablet']}, {'name': 'high dose budesonide tablet', 'type': 'DRUG', 'otherNames': ['BET 2mg BID'], 'description': '2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily', 'armGroupLabels': ['High dose budesonide tablet']}, {'name': 'high dose budesonide suspension', 'type': 'DRUG', 'otherNames': ['BVS 2mg BID'], 'description': 'placebo tablet twice daily AND 5ml \\[0.4mg budesonide/ml\\] suspension twice daily', 'armGroupLabels': ['High dose budesonide suspension']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo tablet twice daily AND 5ml placebo suspension twice daily', 'armGroupLabels': ['Placebo']}]}, '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Falk Pharma GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}