Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT00257569
Status:
COMPLETED
Last Update Posted:
2013-05-06
First Post:
2005-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Of Atopic Dermatitis In Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-03', 'studyFirstSubmitDate': '2005-11-21', 'studyFirstSubmitQcDate': '2005-11-22', 'lastUpdatePostDateStruct': {'date': '2013-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the severity of pruritus'}], 'secondaryOutcomes': [{'measure': '-changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atopic', 'Pediatric', 'Dermatitis'], 'conditions': ['Dermatitis, Atopic']}, 'descriptionModule': {'briefSummary': 'To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children diagnosed as atopic dermatitis\n* Giving informed consent\n* Children who have 2 grades or more pruritus score.\n* Children who require the treatment with external steroid preparation other than face and head.\n* Children with a pruritus severity of 2.\n* Mild or severe on the fist day of the treatment period.\n\nExclusion criteria:\n\n* have spastic disease such as epilepsy\n* have a history of drug hypersensitivity\n* are lactating or possibly pregnant female Children\n* have a skin infection, or with zooparasite such as scabies and pediculosis\n* cannot avoid the use of external steroid classified into strong, strongest or very strong\n* have eczematous otitis externa with perforation in the eardrum\n* have dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2\n* have asthma that requires the treatment with corticosteroid\n* have pruritus only on face and head\n* have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug\n* are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.'}, 'identificationModule': {'nctId': 'NCT00257569', 'briefTitle': 'Study Of Atopic Dermatitis In Pediatrics', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-', 'orgStudyIdInfo': {'id': '104913'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cetirizine Dry Syrup', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}