Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT05488405
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2022-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mesalazine Oral Suspension in Active Eosinophilic Esophagitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D004941', 'term': 'Esophagitis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with histological remission', 'timeFrame': '4 weeks', 'description': 'Assessment of remission of histological signs of EoE'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with histological response', 'timeFrame': '4 weeks', 'description': 'Assessment of improvement of histological signs of EoE'}, {'measure': 'Proportion of patients with improvement of symptoms', 'timeFrame': '4 weeks', 'description': 'Clinical symptoms will be assessed via patient reported outcome measures.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal dysfunction, esophageal inflammation'], 'conditions': ['Eosinophilic Esophagitis']}, 'descriptionModule': {'briefSummary': 'Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis', 'detailedDescription': 'This is an open-label, monocentric exploratory phase IIa pilot study, which serves to evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension for the treatment of active eosinophilic esophagitis (EoE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, '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* Negative pregnancy test in females of childbearing potential\n\nExclusion Criteria:\n\n* Other causes for esophageal eosinophilia\n* Clinical and endoscopic signs of gastroesophageal reflux disease (GERD)\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 known or suspicion for relevant infectious diseases associated with clinical signs,\n* Known intolerance/hypersensitivity/resistance to the IMP or excipients or drugs of similar chemical structure or pharmacological profile\n* Existing or intended pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT05488405', 'briefTitle': 'Mesalazine Oral Suspension in Active Eosinophilic Esophagitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Falk Pharma GmbH'}, 'officialTitle': 'Open-label, Monocentric Phase IIa Pilot Study Evaluating the Efficacy and Tolerability of a 4-week Treatment With Mesalazine Oral Suspension in Patients With Active Eosinophilic Esophagitis', 'orgStudyIdInfo': {'id': 'SAV-1/EEA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesalamine treatment', 'description': 'Treatment of patient with mesalamine oral suspension', 'interventionNames': ['Drug: Mesalamine Oral Product']}], 'interventions': [{'name': 'Mesalamine Oral Product', 'type': 'DRUG', 'otherNames': ['5-ASA'], 'description': 'Mesalamine oral suspension for oral use', 'armGroupLabels': ['Mesalamine treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Luc Biedermann, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UniversitätsSpital Zürich Klinik für Gastroenterologie und Hepatologie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Falk Pharma GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}