Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 12:51 PM
Study NCT ID:
NCT01614834
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2012-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of an Urticaria Control Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D014581', 'term': 'Urticaria'}], 'ancestors': [{'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2012-06-06', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urticaria', 'disease control', 'severity', 'test'], 'conditions': ['Chronic Urticaria']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to validate a previously developed patient reported outcome instrument (in project UCT-D) to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients suffering from chronic forms of urticaria', 'healthyVolunteers': False, 'eligibilityCriteria': 'all patients suffering from chronic forms of urticaria are eligible'}, 'identificationModule': {'nctId': 'NCT01614834', 'acronym': 'UCT-V', 'briefTitle': 'Validation of an Urticaria Control Test', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Development (and Validation) of an Instrument to Assess Disease Control in Patients With Urticaria (Urticaria Control Test)', 'orgStudyIdInfo': {'id': 'UCT-V'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic urticaria patients', 'description': 'all patients suffering from chronic forms of urticaria (chronic spontaneous urticaria as well as chronic inducible forms such as cold contact urticaria)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Universitätshautklinik Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Allergie-Centrum-Charite', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pricipal Investigator', 'investigatorFullName': 'K. Weller', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}