Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-09 @ 4:48 AM
Study NCT ID:
NCT01840605
Status:
COMPLETED
Last Update Posted:
2018-05-25
First Post:
2013-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511534', 'term': 'bepotastine besilate'}, {'id': 'D007665', 'term': 'Ketotifen'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'TAU-284', 'description': 'TAU-284 10mg twice daily for 2 weeks', 'otherNumAtRisk': 151, 'otherNumAffected': 6, 'seriousNumAtRisk': 151, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketotifen Fumarate', 'description': 'Ketotifen fumarate dry syrup 1g twice daily for 2 weeks', 'otherNumAtRisk': 152, 'otherNumAffected': 11, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Pruritus Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAU-284', 'description': 'TAU-284 10mg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Ketotifen Fumarate', 'description': 'Ketotifen fumarate dry syrup 1g twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.669', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '-0.638', 'spread': '0.058', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 2 weeks', 'description': 'The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pruritus Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAU-284', 'description': 'TAU-284 10mg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Ketotifen Fumarate', 'description': 'Ketotifen fumarate dry syrup 1g twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.425', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '-0.510', 'spread': '0.047', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 1 weeks', 'description': 'The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAU-284', 'description': 'TAU-284 10mg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Ketotifen Fumarate', 'description': 'Ketotifen fumarate dry syrup 1g twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAU-284', 'description': 'TAU-284 10mg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'Ketotifen Fumarate', 'description': 'Ketotifen fumarate dry syrup 1g twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000', 'lowerLimit': '57.4', 'upperLimit': '73.1'}, {'value': '65.1', 'groupId': 'OG001', 'lowerLimit': '57.0', 'upperLimit': '72.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'description': 'Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAU-284', 'description': 'TAU-284 10mg twice daily for 2 weeks'}, {'id': 'FG001', 'title': 'Ketotifen Fumarate', 'description': 'Ketotifen fumarate dry syrup 1g twice daily for 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAU-284', 'description': 'TAU-284 10mg twice daily for 2 weeks'}, {'id': 'BG001', 'title': 'Ketotifen Fumarate', 'description': 'Ketotifen fumarate dry syrup 1g twice daily for 2 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '10.4', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '10.3', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2013-04-23', 'resultsFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2013-04-23', 'lastUpdatePostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-17', 'studyFirstPostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Pruritus Score', 'timeFrame': 'Baseline and 2 weeks', 'description': 'The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Pruritus Score', 'timeFrame': 'Baseline and 1 weeks', 'description': 'The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).'}, {'measure': 'Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)', 'timeFrame': 'Baseline and 2 weeks', 'description': 'Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).'}, {'measure': 'Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)', 'timeFrame': 'Week 2', 'description': 'Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dermatitis', 'Atopic']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Kawashima M; Ichimura M; Yano K; Susuta Y; Izaki H. Phase III study of bepotastine besilate in children with atopic dermatitis -A randomized, double-blind, parallel-group, comparative study with ketotifen fumarate dry syrup- Rinsho iyaku 2015 Mar;31(3):235-251'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.', 'detailedDescription': 'This is a randomized, double-blind, parallel-group comparative study to demonstrate the noninferiority of TAU-284 to ketotifen fumarate in pediatric patients with atopic dermatitis, as assessed by the primary endpoint of the change from baseline in pruritus score after 2-week treatment with TAU-284 (20 mg/day) or ketotifen fumarate dry syrup (2 g/day); and to investigate the safety, and plasma concentrations of TAU-284.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 7 and 15 years\n* Patients giving assent and whose legal guardian giving informed consent\n* Outpatients\n* Patients diagnosed as atopic dermatitis\n* Patients who require the treatment with topical corticosteroid on areas other than face, head and neck\n* Patients whose diaries can be properly maintained\n* Patients who have 2 grades or more pruritus score\n\nExclusion Criteria:\n\n* Patients with bronchial asthma who require concomitant use of the corticosteroid\n* Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy\n* Patients with current or previous history of drug hypersensitivity\n* Patients who have been treated with Bepotastine besilate in the past\n* Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied\n* Patients who have spastic disease such as epilepsy\n* Patients who concurrently have renal function abnormalities that may cause safety problems\n* Patients who do not give consent to use birth control\n* Pregnant patients, at risk of pregnancy or breastfeeding\n* Patients who had participated in any clinical trial in the last 12 weeks'}, 'identificationModule': {'nctId': 'NCT01840605', 'briefTitle': 'A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)', 'orgStudyIdInfo': {'id': 'TAU-284-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAU-284', 'description': 'Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day, once after breakfast and once before bed.', 'interventionNames': ['Drug: Bepotastine besilate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ketotifen fumarate', 'description': 'Two TAU-284 5mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day, once after breakfast and once before bed.', 'interventionNames': ['Drug: ketotifen fumarate']}], 'interventions': [{'name': 'Bepotastine besilate', 'type': 'DRUG', 'otherNames': ['TALION 5mg tablets'], 'description': 'Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day', 'armGroupLabels': ['TAU-284']}, {'name': 'ketotifen fumarate', 'type': 'DRUG', 'otherNames': ['ketotifen fumarate dry syrup'], 'description': 'Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day', 'armGroupLabels': ['ketotifen fumarate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Medical Corporation Kojinkai Asanuma Dermatology Clinic'}], 'overallOfficials': [{'name': 'MAKOTO KAWASHIMA', 'role': 'STUDY_DIRECTOR', 'affiliation': "Tokyo Women's Medical University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}