Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-29 @ 10:13 PM
Study NCT ID:
NCT00780403
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2008-10-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications (Study P04573) (Completed)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': "The only disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and sponsor's representative will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'RediTab/Zyrtec', 'description': 'Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).', 'otherNumAtRisk': 109, 'otherNumAffected': 0, 'seriousNumAtRisk': 109, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Zyrtec/RediTab', 'description': 'Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).', 'otherNumAtRisk': 111, 'otherNumAffected': 0, 'seriousNumAtRisk': 111, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}, {'value': '220', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RediTab', 'description': 'All randomized subjects.'}, {'id': 'OG001', 'title': 'Zyrtec', 'description': 'All randomized subjects.'}, {'id': 'OG002', 'title': 'No Preference', 'description': 'All randomized subjects.'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Statistical tests were performed at the significance level of 5%, without multiplicity adjustment.', 'groupDescription': 'The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.', 'statisticalMethod': 'Mainland-Gart Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.'}], 'paramType': 'NUMBER', 'timeFrame': 'Following the second dose (8-10 minutes after the first dose)', 'description': 'A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject "now that you have tasted the two tablets, show us which tablet you like more" and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RediTab/Zyrtec', 'description': 'Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).'}, {'id': 'FG001', 'title': 'Zyrtec/RediTab', 'description': 'Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Interval Between Doses (8-10 Minutes)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Population', 'description': 'All randomized subjects.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '1.65', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2008-10-23', 'resultsFirstSubmitDate': '2010-02-17', 'studyFirstSubmitQcDate': '2008-10-23', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-07-02', 'studyFirstPostDateStruct': {'date': '2008-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.', 'timeFrame': 'Following the second dose (8-10 minutes after the first dose)', 'description': 'A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject "now that you have tasted the two tablets, show us which tablet you like more" and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergies']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to determine whether children ages 6-11 years prefer desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The secondary objectives of this study were to compare acceptance of the two attributes, taste and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject and the parent/guardian of the subject, was to have demonstrated their willingness to participate in the study and comply with its procedures by signing a written Informed Consent\n* 6-11 years old, either sex, either race\n* If female, subject to be premenarcheal\n* Willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.\n* Free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.\n* Able to adhere to the dosing and visit schedules\n\nExclusion Criteria:\n\n* If female, subject who was pregnant, intended to become pregnant during the study or nursing.\n* Subject had used any investigational product within 30 days prior to enrollment.\n* Subject had any of the following clinical conditions: history of any significant medical conditions (based on reporting by parent or guardian): e.g., diabetes, heart disease, liver disease, kidney disease, breathing problems, cough with excessive phlegm, or persistent or chronic cough.\n* Subject had a current medical condition that, in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, allergic rhinitis, etc.).\n* Subject was participating in any other clinical study(ies).\n* Subject was part of the staff or a family member of the staff personnel directly involved with this study.\n* Subject was allergic to or has sensitivity to the study drug or its excipients.\n* Subject had a history of allergic reaction to prescription and/or over the counter (OTC) medications and/or food products.\n* Subject had used any antihistamines within 24 hours prior to tasting as outlined in Section 9.4.7.\n* Subject used sedatives, tranquilizers, or monoamine oxidase inhibitor drugs.'}, 'identificationModule': {'nctId': 'NCT00780403', 'briefTitle': 'Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications (Study P04573) (Completed)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications', 'orgStudyIdInfo': {'id': 'P04573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RediTab/Zyrtec', 'description': 'Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference.', 'interventionNames': ['Drug: Desloratadine', 'Drug: Zyrtec® (cetirizine)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zyrtec/RediTab', 'description': 'Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference.', 'interventionNames': ['Drug: Desloratadine', 'Drug: Zyrtec® (cetirizine)']}], 'interventions': [{'name': 'Desloratadine', 'type': 'DRUG', 'otherNames': ['SCH 034117'], 'description': 'desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day', 'armGroupLabels': ['RediTab/Zyrtec', 'Zyrtec/RediTab']}, {'name': 'Zyrtec® (cetirizine)', 'type': 'DRUG', 'description': 'Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day', 'armGroupLabels': ['RediTab/Zyrtec', 'Zyrtec/RediTab']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}