Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT00264303
Status:
COMPLETED
Last Update Posted:
2011-08-31
First Post:
2005-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CUTE (Chronic Urticaria Treatment Evaluation)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}], 'ancestors': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C472067', 'term': 'levocetirizine'}, {'id': 'C121345', 'term': 'desloratadine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'UCB Clinical Trial Call Center', 'organization': 'UCB Pharma'}, 'certainAgreement': {'otherDetails': 'UCB has \\> 60 days but \\<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Levocetirizine 5 mg', 'description': 'Levocetirizine 5 mg once daily for four weeks', 'otherNumAtRisk': 438, 'otherNumAffected': 80, 'seriousNumAtRisk': 438, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Desloratadine 5 mg', 'description': 'Desloratadine 5 mg once daily for four weeks', 'otherNumAtRisk': 448, 'otherNumAffected': 77, 'seriousNumAtRisk': 448, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 448, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 448, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 448, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 448, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 448, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Diabetes Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 448, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levocetirizine 5 mg', 'description': 'Levocetirizine 5 mg once daily for four weeks'}, {'id': 'OG001', 'title': 'Desloratadine 5 mg', 'description': 'Desloratadine 5 mg once daily for four weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.98', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.43', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over the first week of treatment', 'description': 'CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or \\<=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or \\>50 wheals/24 h). Mean is averaged over the 1st week of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levocetirizine 5 mg', 'description': 'Levocetirizine 5 mg once daily for four weeks'}, {'id': 'OG001', 'title': 'Desloratadine 5 mg', 'description': 'Desloratadine 5 mg once daily for four weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.34', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over the four weeks of treatment', 'description': 'CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or \\<=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or \\>50 wheals/24 h). Mean is averaged over the 4 weeks of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Mean Pruritus Severity Score Over the Four Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levocetirizine 5 mg', 'description': 'Levocetirizine 5 mg once daily for four weeks'}, {'id': 'OG001', 'title': 'Desloratadine 5 mg', 'description': 'Desloratadine 5 mg once daily for four weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.22', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and pooled center as factors and baseline pruritus severity score as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over the four weeks of treatment', 'description': 'Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Mean Score for Pruritus Duration Over the First Week of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levocetirizine 5 mg', 'description': 'Levocetirizine 5 mg once daily for four weeks'}, {'id': 'OG001', 'title': 'Desloratadine 5 mg', 'description': 'Desloratadine 5 mg once daily for four weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.26', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and pooled center as factors and baseline pruritus duration as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over the first week of treatment', 'description': 'The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Mean Score for Pruritus Duration Over the Four Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levocetirizine 5 mg', 'description': 'Levocetirizine 5 mg once daily for four weeks'}, {'id': 'OG001', 'title': 'Desloratadine 5 mg', 'description': 'Desloratadine 5 mg once daily for four weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.22', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and pooled centers as factors and baseline pruritus duration score as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over the four weeks of treatment', 'description': 'The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) Population'}, {'type': 'PRIMARY', 'title': 'Mean Pruritus Severity Score Over the First Week of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levocetirizine 5 mg', 'description': 'Levocetirizine 5 mg once daily for four weeks'}, {'id': 'OG001', 'title': 'Desloratadine 5 mg', 'description': 'Desloratadine 5 mg once daily for four weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.26', 'groupDescription': 'The primary hypothesis to be tested in this study was that the clinical efficacy of Levocetirizine 5 mg is superior to that of Desloratidine 5 mg', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and pooled center as factors and baseline severity as covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over the first week of treatment', 'description': 'Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levocetirizine 5 mg', 'description': 'Levocetirizine 5 mg once daily for four weeks'}, {'id': 'FG001', 'title': 'Desloratadine 5 mg', 'description': 'Desloratadine 5 mg once daily for four weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '438'}, {'groupId': 'FG001', 'numSubjects': '448'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '419'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Various reasons listed in study report', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': '976 patients have been screened for this study. Ninety patients were ineligible for randomization, 886 have been randomized and treated. Participants flow and Baseline Characteristics refer to all patients randomized and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'BG000'}, {'value': '448', 'groupId': 'BG001'}, {'value': '886', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Levocetirizine 5 mg', 'description': 'Levocetirizine 5 mg once daily for four weeks'}, {'id': 'BG001', 'title': 'Desloratadine 5 mg', 'description': 'Desloratadine 5 mg once daily for four weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'spread': '15.3', 'groupId': 'BG000'}, {'value': '42.9', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '43.1', 'spread': '15.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '590', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 886}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-30', 'studyFirstSubmitDate': '2005-12-08', 'resultsFirstSubmitDate': '2009-05-18', 'studyFirstSubmitQcDate': '2005-12-08', 'lastUpdatePostDateStruct': {'date': '2011-08-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-05-18', 'studyFirstPostDateStruct': {'date': '2005-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Pruritus Severity Score Over the First Week of Treatment', 'timeFrame': 'over the first week of treatment', 'description': 'Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.'}], 'secondaryOutcomes': [{'measure': 'Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment', 'timeFrame': 'over the first week of treatment', 'description': 'CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or \\<=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or \\>50 wheals/24 h). Mean is averaged over the 1st week of treatment.'}, {'measure': 'Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment', 'timeFrame': 'over the four weeks of treatment', 'description': 'CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or \\<=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or \\>50 wheals/24 h). Mean is averaged over the 4 weeks of treatment.'}, {'measure': 'Mean Pruritus Severity Score Over the Four Weeks of Treatment', 'timeFrame': 'over the four weeks of treatment', 'description': 'Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment.'}, {'measure': 'Mean Score for Pruritus Duration Over the First Week of Treatment', 'timeFrame': 'over the first week of treatment', 'description': 'The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment.'}, {'measure': 'Mean Score for Pruritus Duration Over the Four Weeks of Treatment', 'timeFrame': 'over the four weeks of treatment', 'description': 'The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment.'}]}, 'conditionsModule': {'keywords': ['Chronic Idiopathic Urticaria', 'CUTE Levocetirizine Xyzal®'], 'conditions': ['Chronic Idiopathic Urticaria']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- At visit 1: Clinical history of Chronic Idiopathic Urticaria for a period of at least 6 weeks during the last 3 months without an identifiable cause\n\n\\- At visit 2 (after a baseline period of at least 3 days): patient with adequate signs of CIU, both in terms of symptoms and severity.\n\nExclusion Criteria:\n\n\\- Any condition that would interfere with the evaluation of the therapeutic response.'}, 'identificationModule': {'nctId': 'NCT00264303', 'briefTitle': 'CUTE (Chronic Urticaria Treatment Evaluation)', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Comparative Study on Clinical Efficacy and Safety of Levocetirizine 5 mg Oral Capsules Once Daily in the Morning vs. Desloratadine 5 mg Oral Capsules Once Daily in the Morning in Patients Suffering From Chronic Idiopathic Urticaria (CIU)', 'orgStudyIdInfo': {'id': 'A00394'}, 'secondaryIdInfos': [{'id': 'EudraCT 2005-000358-65'}, {'id': 'CUTE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levocetirizine', 'description': 'Levocetirizine, once daily, 4 week duration', 'interventionNames': ['Drug: Levocetirizine']}, 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