Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-04-11 @ 10:58 AM
Study NCT ID:
NCT00794794
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2008-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03826)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C121345', 'term': 'desloratadine'}, {'id': 'D017332', 'term': 'Cetirizine'}], 'ancestors': [{'id': 'D006919', 'term': 'Hydroxyzine'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2008-11-19', 'studyFirstSubmitQcDate': '2008-11-19', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face).', 'timeFrame': 'During the only study visit'}], 'secondaryOutcomes': [{'measure': 'Taste flavor preference between bubble-gum, banana-grape, or grape flavors', 'timeFrame': 'During the only study visit'}, {'measure': 'Adverse Events', 'timeFrame': 'During the only study visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.', 'detailedDescription': 'This study is a cross-over study design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects must be:\n\n* Between 6 and 11 years of age in good general health\n* Premenarcheal if female\n\nExclusion Criteria:\n\nSubjects who:\n\n* Have known allergies or sensitivities to either of the drug formulations\n* Have a medical condition that may interfere with the subject's ability to discriminate between tastes\n* Have used any antihistamines within 24 hours prior to dosing\n* Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs\n* Were involved in another clinical or market research study within the past 30 days"}, 'identificationModule': {'nctId': 'NCT00794794', 'briefTitle': 'Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03826)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications', 'orgStudyIdInfo': {'id': 'P03826'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desloratadine and Cetirizine Crossover', 'description': 'To compare the preference in taste between desloratadine and cetirizine.', 'interventionNames': ['Drug: Desloratadine (Clarinex)', 'Drug: Cetirizine (Zyrtec)']}], 'interventions': [{'name': 'Desloratadine (Clarinex)', 'type': 'DRUG', 'otherNames': ['SCH 034117, Clarinex'], 'description': 'Each subject received 5 mL of desloratadine syrup one time', 'armGroupLabels': ['Desloratadine and Cetirizine Crossover']}, {'name': 'Cetirizine (Zyrtec)', 'type': 'DRUG', 'otherNames': ['Zyrtec'], 'description': 'Each subject received 5 mL of cetirizine syrup', 'armGroupLabels': ['Desloratadine and Cetirizine Crossover']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}