Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-01 @ 11:57 PM
Study NCT ID:
NCT00257595
Status:
COMPLETED
Last Update Posted:
2013-05-06
First Post:
2005-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perennial Allergic Rhinitis In Pediatric Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, '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': 'safety'}], 'secondaryOutcomes': [{'measure': 'Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Perennial Allergic Rhinitis pediatric'], 'conditions': ['Rhinitis, Allergic, Perennial']}, 'descriptionModule': {'briefSummary': 'To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with perennial allergic rhinitis.\n* Giving informed consent.\n* Children with a positive response to specific IgE antibody test.\n* Children assessed as positive in the nasal eosinophil count.\n* Children whose severity score of nasal symptom is 4 or higher.\n\nExclusion criteria:\n\n* have a history of drug hypersensitivity.\n* are pregnant, lactating or possibly pregnant female children.\n* Sensitivity to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods.\n* have vasomotor rhinitis and eosinophilic rhinitis.\n* have asthma that requires the treatment with corticosteroid.\n* have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs.\n* have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation.\n* have started specific desensitization treatment.\n* nonspecific modulation treatment but who have not reached the maintenance level of treatment.\n* have received surgical treatment for reduction and modulation of nasal mucosa.\n* redintegration therapy of nasal cavity to improve the degree of nasal airway.\n* surgical operation to improve rhinorrhea.'}, 'identificationModule': {'nctId': 'NCT00257595', 'briefTitle': 'Perennial Allergic Rhinitis In Pediatric Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.', 'orgStudyIdInfo': {'id': '104914'}}, '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'}}}}