Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT00638456
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2008-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}, {'id': 'D004941', 'term': 'Esophagitis'}], 'ancestors': [{'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': 'D064747', 'term': 'Lansoprazole'}], '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'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rdohil@ucsd.edu', 'phone': '(858) 966-4003', 'title': 'Dr. Ranjan Dohil', 'organization': 'Univeristy of California, San Diego'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oral Viscous Budesonide Plus Prevacid', 'description': 'Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 3, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Plus Prevacid', 'description': 'placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 5, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Oral Candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Trasient headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Worsening Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Chest Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Mild Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'transient diarrehea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Improvement of Espohageal Eosinophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide Plus Prevacid', 'description': 'Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.'}, {'id': 'OG001', 'title': 'Placebo Plus Prevacid', 'description': 'placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 Months', 'description': 'Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 subjects withdrew from the oral viscous budesonide plus Prevacid group and 2 withdrew from the placebo plus Prevacid group, and so they were not included in the data analsyis.'}, {'type': 'SECONDARY', 'title': 'Upper Gastrointestinal Endoscopy Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide Plus Prevacid', 'description': 'Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.'}, {'id': 'OG001', 'title': 'Placebo Plus Prevacid', 'description': 'placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '9'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 Months', 'description': 'Endoscopy scoring tool took into account the following categories:\n\nMucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count\n\nEach category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide Plus Prevacid', 'description': 'Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.'}, {'id': 'OG001', 'title': 'Placebo Plus Prevacid', 'description': 'placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 Months', 'description': 'Total score was based on the following symptoms:\n\nHeartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding\n\nEach symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Viscous Budesonide Plus Prevacid', 'description': 'Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.'}, {'id': 'FG001', 'title': 'Placebo Plus Prevacid', 'description': 'placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Viscous Budesonide Plus Prevacid', 'description': 'Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.'}, {'id': 'BG001', 'title': 'Placebo Plus Prevacid', 'description': 'placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2008-03-12', 'resultsFirstSubmitDate': '2019-07-25', 'studyFirstSubmitQcDate': '2008-03-18', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-25', 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Improvement of Espohageal Eosinophilia', 'timeFrame': '3 Months', 'description': 'Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.'}], 'secondaryOutcomes': [{'measure': 'Upper Gastrointestinal Endoscopy Score', 'timeFrame': 'Baseline and 3 Months', 'description': 'Endoscopy scoring tool took into account the following categories:\n\nMucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count\n\nEach category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease.'}, {'measure': 'Symptom Score', 'timeFrame': 'Baseline and 3 Months', 'description': 'Total score was based on the following symptoms:\n\nHeartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding\n\nEach symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Eosinophils', 'Esophagitis', 'Microscopy'], 'conditions': ['Eosinophilic Esophagitis']}, 'referencesModule': {'references': [{'pmid': '20457157', 'type': 'DERIVED', 'citation': 'Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy\n* Ages 1 yrs and older\n* Ability to continue the same diet that the patient was on at the time of EGD with biopsy\n\nExclusion Criteria:\n\n* Adverse reaction or allergy to budesonide\n* Pregnancy\n* Chronic diseases requiring immunomodulatory therapy\n* Use of swallowed topical corticosteroids for EE within the past 3 months\n* Use of systemic steroids 2 months prior to study entry\n* Upper gastrointestinal bleed within 4 months of study entry\n* Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants\n* Evidence of adrenal suppression prior to study entry\n* Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis\n* Recent changes in asthma or allergic rhinitis therapy for 3 months'}, 'identificationModule': {'nctId': 'NCT00638456', 'briefTitle': 'Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'VPI-106-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'oral viscous budesonide plus Prevacid', 'interventionNames': ['Drug: Budesonide plus Prevacid']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo plus Prevacid', 'interventionNames': ['Drug: placebo plus Prevacid']}], 'interventions': [{'name': 'Budesonide plus Prevacid', 'type': 'DRUG', 'description': 'Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.', 'armGroupLabels': ['1']}, {'name': 'placebo plus Prevacid', 'type': 'DRUG', 'description': 'Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital, San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Ranjan Dohil, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ranjan Dohil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Meritage Pharma, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ranjan Dohil', 'investigatorAffiliation': 'University of California, San Diego'}}}}