Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT01425632
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2011-08-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108476', 'term': 'bepotastine'}]}}, '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 Low', 'description': 'TAU-284 5mg twice daily for 2 weeks', 'otherNumAtRisk': 161, 'otherNumAffected': 17, 'seriousNumAtRisk': 161, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TAU-284 High', 'description': 'TAU-284 10mg twice daily for 2 weeks', 'otherNumAtRisk': 166, 'otherNumAffected': 8, 'seriousNumAtRisk': 166, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'TAU-284 placebo twice daily for 2 weeks', 'otherNumAtRisk': 163, 'otherNumAffected': 15, 'seriousNumAtRisk': 163, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 166, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 163, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 166, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 163, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 166, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TAU-284 Low', 'description': 'TAU-284 5mg twice daily for 2 weeks'}, {'id': 'OG001', 'title': 'TAU-284 High', 'description': 'TAU-284 10mg twice daily for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'TAU-284 placebo twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '0.12', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 2', 'description': 'Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]', 'timeFrame': 'Week 2', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)', 'timeFrame': 'Week 2', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)', 'timeFrame': 'Week 2', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity Score', 'timeFrame': 'Week 2', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events and Adverse Drug Reactions', 'timeFrame': 'Week 2', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)', 'timeFrame': 'Week 2', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAU-284 Low', 'description': 'TAU-284 5mg twice daily for 2 weeks'}, {'id': 'FG001', 'title': 'TAU-284 High', 'description': 'TAU-284 10mg twice daily for 2 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'TAU-284 placebo twice daily for 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '166'}, {'groupId': 'FG002', 'numSubjects': '163'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '165'}, {'groupId': 'FG002', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '490', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'TAU-284 Low', 'description': 'TAU-284 5mg twice daily for 2 weeks'}, {'id': 'BG001', 'title': 'TAU-284 High', 'description': 'TAU-284 10mg twice daily for 2 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'TAU-284 placebo twice daily for 2 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '11.4', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '11.2', 'spread': '2.5', 'groupId': 'BG002'}, {'value': '11.2', 'spread': '2.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '292', 'groupId': 'BG003'}]}]}], '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': 490}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '2011-08-28', 'resultsFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2011-08-28', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-10', 'studyFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)', 'timeFrame': 'Baseline and Week 2', 'description': 'Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]', 'timeFrame': 'Week 2'}, {'measure': 'Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)', 'timeFrame': 'Week 2'}, {'measure': 'Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)', 'timeFrame': 'Week 2'}, {'measure': 'Change From Baseline in Severity Score', 'timeFrame': 'Week 2'}, {'measure': 'Adverse Events and Adverse Drug Reactions', 'timeFrame': 'Week 2'}, {'measure': 'Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)', 'timeFrame': 'Week 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TAU-284', 'Bepotastine besilate', 'Histamine H1 receptor antagonists'], 'conditions': ['Perennial Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis, and to investigate the dose response, safety, and plasma concentrations of TAU-284.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms \\[sneezing, rhinorrhea, and nasal congestion\\])" as the primary endpoint; and to investigate the dose response, 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 with a weight of at least 20 kg\n* Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria\n* Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms \\[sneezing, rhinorrhea, and nasal congestion\\] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period\n\nExclusion Criteria:\n\n* Patients with vasomotor rhinitis or eosinophilic rhinitis\n* Patients who have concurrent nasal disease that may affect the efficacy of TAU-284\n* Patients with a history of any of the nasal surgical procedures\n* Patients who have a positive result for pollen antigens which are dispersed during the study period\n* Patients who have a positive result for dog dander or cat dander antigen\n* Patients with current or previous history of drug allergy\n* Patients who concurrently have renal function abnormalities that may cause safety problems'}, 'identificationModule': {'nctId': 'NCT01425632', 'briefTitle': 'A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)', 'orgStudyIdInfo': {'id': 'TAU-284-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAU-284 Low', 'interventionNames': ['Drug: TAU-284']}, {'type': 'EXPERIMENTAL', 'label': 'TAU-284 High', 'interventionNames': ['Drug: TAU-284']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TAU-284', 'type': 'DRUG', 'description': 'TAU-284 Low', 'armGroupLabels': ['TAU-284 Low']}, {'name': 'TAU-284', 'type': 'DRUG', 'description': 'TAU-284 High', 'armGroupLabels': ['TAU-284 High']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chūbu', 'country': 'Japan', 'facility': 'Reserch site', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokuriku', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Reserch site'}, {'city': 'Kyusyu', 'country': 'Japan', 'facility': 'Reserch site'}], 'overallOfficials': [{'name': 'Kimihiro Okubo, M.D. Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Otorhinolaryngology, Nippon Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}