Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT00819494
Status:
COMPLETED
Last Update Posted:
2010-11-18
First Post:
2009-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D003287', 'term': 'Contrast Media'}], 'ancestors': [{'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D064907', 'term': 'Diagnostic Uses of Chemicals'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-17', 'studyFirstSubmitDate': '2009-01-08', 'studyFirstSubmitQcDate': '2009-01-08', 'lastUpdatePostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of positive wheal and flare responses from skin test in patients with a history of immediate reactions to radiocontrast media', 'timeFrame': '5 months'}], 'secondaryOutcomes': [{'measure': 'Blood in vitro test from patients with a history of immediate reactions to radiocontrast media', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contrast media skin test', 'Skin test', 'hypersensitivity', 'contrast media'], 'conditions': ['Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study the diagnostic role of skin test in immediate reactions to iodinated radiocontrast media.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with history of immediate hypersensitivity reactions to iodinated contrast media\n2. 15-70 years of age\n\nExclusion Criteria:\n\n1. On antihistamine/ cannot discontinue antihistamine before the test\n2. Having asthma exacerbation\n3. Being pregnant\n4. Suffering from severe systemic disease/ in bad health'}, 'identificationModule': {'nctId': 'NCT00819494', 'briefTitle': 'Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media', 'orgStudyIdInfo': {'id': 'Chula-ARC 003/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Healthy controls', 'interventionNames': ['Procedure: Skin tests with radiocontrast media']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with immediate reactions', 'interventionNames': ['Procedure: Skin tests with radiocontrast media']}], 'interventions': [{'name': 'Skin tests with radiocontrast media', 'type': 'PROCEDURE', 'description': 'Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media', 'armGroupLabels': ['Healthy controls', 'Patients with immediate reactions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Kiat Ruxrungtham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jettanong Klaewsongkram, MD', 'oldOrganization': 'Chulalongkorn University'}}}}