Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-01 @ 5:32 PM
Study NCT ID:
NCT01916967
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2013-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C121345', 'term': 'desloratadine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 weeks (Up to 2 weeks after last dose of study drug)', 'description': 'The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.', 'eventGroups': [{'id': 'EG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks', 'otherNumAtRisk': 80, 'otherNumAffected': 10, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks', 'otherNumAtRisk': 79, 'otherNumAffected': 8, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks', 'otherNumAtRisk': 79, 'otherNumAffected': 5, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Desloratadine 5 mg→Placebo', 'description': 'Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.19', 'groupId': 'OG000', 'lowerLimit': '-3.56', 'upperLimit': '-2.83'}, {'value': '-3.16', 'groupId': 'OG001', 'lowerLimit': '-3.52', 'upperLimit': '-2.79'}, {'value': '-2.02', 'groupId': 'OG002', 'lowerLimit': '-2.40', 'upperLimit': '-1.65'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.17', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '-0.65', 'groupDescription': 'Difference in least squares (LS) means of Desloratadine 5 mg and Placebo', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.13', 'ciLowerLimit': '-1.66', 'ciUpperLimit': '-0.61', 'groupDescription': 'Difference in LS means of Desloratadine 10 mg and Placebo', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Visit and Week 2 Visit', 'description': 'The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and a Week 2 assessment for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG003', 'title': 'Desloratadine 5 mg→Placebo', 'description': 'Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks (Up to 2 weeks after last dose of study drug)', 'description': 'An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG003', 'title': 'Desloratadine 5 mg→Placebo', 'description': 'Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 weeks', 'description': 'An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}], 'classes': [{'title': 'Change from Baseline at Day 3', 'categories': [{'measurements': [{'value': '-2.57', 'groupId': 'OG000', 'lowerLimit': '-2.91', 'upperLimit': '-2.23'}, {'value': '-2.75', 'groupId': 'OG001', 'lowerLimit': '-3.09', 'upperLimit': '-2.41'}, {'value': '-0.80', 'groupId': 'OG002', 'lowerLimit': '-1.14', 'upperLimit': '-0.46'}]}]}, {'title': 'Change from Baseline at Week 1', 'categories': [{'measurements': [{'value': '-3.01', 'groupId': 'OG000', 'lowerLimit': '-3.34', 'upperLimit': '-2.68'}, {'value': '-3.16', 'groupId': 'OG001', 'lowerLimit': '-3.50', 'upperLimit': '-2.83'}, {'value': '-1.39', 'groupId': 'OG002', 'lowerLimit': '-1.72', 'upperLimit': '-1.06'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit', 'description': 'The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}], 'classes': [{'title': 'Change from Baseline at Day 3', 'categories': [{'measurements': [{'value': '-2.62', 'groupId': 'OG000', 'lowerLimit': '-2.97', 'upperLimit': '-2.27'}, {'value': '-2.72', 'groupId': 'OG001', 'lowerLimit': '-3.07', 'upperLimit': '-2.37'}, {'value': '-0.61', 'groupId': 'OG002', 'lowerLimit': '-0.95', 'upperLimit': '-0.26'}]}]}, {'title': 'Change from Baseline at Week 1', 'categories': [{'measurements': [{'value': '-2.98', 'groupId': 'OG000', 'lowerLimit': '-3.35', 'upperLimit': '-2.61'}, {'value': '-3.13', 'groupId': 'OG001', 'lowerLimit': '-3.50', 'upperLimit': '-2.76'}, {'value': '-1.38', 'groupId': 'OG002', 'lowerLimit': '-1.75', 'upperLimit': '-1.01'}]}]}, {'title': 'Change from Baseline at Week 2', 'categories': [{'measurements': [{'value': '-3.17', 'groupId': 'OG000', 'lowerLimit': '-3.56', 'upperLimit': '-2.77'}, {'value': '-3.21', 'groupId': 'OG001', 'lowerLimit': '-3.60', 'upperLimit': '-2.81'}, {'value': '-1.91', 'groupId': 'OG002', 'lowerLimit': '-2.31', 'upperLimit': '-1.50'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}], 'classes': [{'title': 'Change from Baseline at Day 3', 'categories': [{'measurements': [{'value': '-2.31', 'groupId': 'OG000', 'lowerLimit': '-2.63', 'upperLimit': '-2.00'}, {'value': '-2.61', 'groupId': 'OG001', 'lowerLimit': '-2.93', 'upperLimit': '-2.29'}, {'value': '-0.99', 'groupId': 'OG002', 'lowerLimit': '-1.31', 'upperLimit': '-0.67'}]}]}, {'title': 'Change from Baseline at Week 1', 'categories': [{'measurements': [{'value': '-2.65', 'groupId': 'OG000', 'lowerLimit': '-2.97', 'upperLimit': '-2.33'}, {'value': '-2.98', 'groupId': 'OG001', 'lowerLimit': '-3.30', 'upperLimit': '-2.66'}, {'value': '-1.44', 'groupId': 'OG002', 'lowerLimit': '-1.76', 'upperLimit': '-1.12'}]}]}, {'title': 'Change from Baseline at Week 2', 'categories': [{'measurements': [{'value': '-2.94', 'groupId': 'OG000', 'lowerLimit': '-3.28', 'upperLimit': '-2.61'}, {'value': '-2.91', 'groupId': 'OG001', 'lowerLimit': '-3.25', 'upperLimit': '-2.57'}, {'value': '-1.98', 'groupId': 'OG002', 'lowerLimit': '-2.33', 'upperLimit': '-1.64'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}], 'classes': [{'title': 'Change from Baseline at Day 3', 'categories': [{'measurements': [{'value': '-2.37', 'groupId': 'OG000', 'lowerLimit': '-2.74', 'upperLimit': '-2.00'}, {'value': '-2.73', 'groupId': 'OG001', 'lowerLimit': '-3.10', 'upperLimit': '-2.36'}, {'value': '-0.50', 'groupId': 'OG002', 'lowerLimit': '-0.87', 'upperLimit': '-0.13'}]}]}, {'title': 'Change from Baseline at Week 1', 'categories': [{'measurements': [{'value': '-2.53', 'groupId': 'OG000', 'lowerLimit': '-2.91', 'upperLimit': '-2.15'}, {'value': '-2.85', 'groupId': 'OG001', 'lowerLimit': '-3.24', 'upperLimit': '-2.47'}, {'value': '-1.27', 'groupId': 'OG002', 'lowerLimit': '-1.65', 'upperLimit': '-0.88'}]}]}, {'title': 'Change from Baseline at Week 2', 'categories': [{'measurements': [{'value': '-2.85', 'groupId': 'OG000', 'lowerLimit': '-3.30', 'upperLimit': '-2.41'}, {'value': '-2.97', 'groupId': 'OG001', 'lowerLimit': '-3.42', 'upperLimit': '-2.51'}, {'value': '-1.75', 'groupId': 'OG002', 'lowerLimit': '-2.23', 'upperLimit': '-1.27'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}], 'classes': [{'title': 'Change from Baseline at Day 3', 'categories': [{'measurements': [{'value': '-35.94', 'groupId': 'OG000', 'lowerLimit': '-41.91', 'upperLimit': '-29.97'}, {'value': '-39.60', 'groupId': 'OG001', 'lowerLimit': '-45.61', 'upperLimit': '-33.60'}, {'value': '-5.22', 'groupId': 'OG002', 'lowerLimit': '-11.19', 'upperLimit': '0.75'}]}]}, {'title': 'Change from Baseline at Week 1', 'categories': [{'measurements': [{'value': '-40.82', 'groupId': 'OG000', 'lowerLimit': '-46.55', 'upperLimit': '-35.09'}, {'value': '-48.82', 'groupId': 'OG001', 'lowerLimit': '-54.60', 'upperLimit': '-43.03'}, {'value': '-15.88', 'groupId': 'OG002', 'lowerLimit': '-21.63', 'upperLimit': '-10.13'}]}]}, {'title': 'Change from Baseline at Week 2', 'categories': [{'measurements': [{'value': '-45.86', 'groupId': 'OG000', 'lowerLimit': '-51.96', 'upperLimit': '-39.75'}, {'value': '-45.01', 'groupId': 'OG001', 'lowerLimit': '-51.17', 'upperLimit': '-38.84'}, {'value': '-25.24', 'groupId': 'OG002', 'lowerLimit': '-31.52', 'upperLimit': '-18.97'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}], 'classes': [{'title': 'Change from Baseline at Day 3', 'categories': [{'measurements': [{'value': '-2.21', 'groupId': 'OG000', 'lowerLimit': '-2.57', 'upperLimit': '-1.85'}, {'value': '-2.31', 'groupId': 'OG001', 'lowerLimit': '-2.67', 'upperLimit': '-1.94'}, {'value': '-0.77', 'groupId': 'OG002', 'lowerLimit': '-1.13', 'upperLimit': '-0.40'}]}]}, {'title': 'Change from Baseline at Week 1', 'categories': [{'measurements': [{'value': '-2.15', 'groupId': 'OG000', 'lowerLimit': '-2.50', 'upperLimit': '-1.81'}, {'value': '-2.43', 'groupId': 'OG001', 'lowerLimit': '-2.77', 'upperLimit': '-2.08'}, {'value': '-1.17', 'groupId': 'OG002', 'lowerLimit': '-1.52', 'upperLimit': '-0.83'}]}]}, {'title': 'Change from Baseline at Week 2', 'categories': [{'measurements': [{'value': '-2.51', 'groupId': 'OG000', 'lowerLimit': '-2.88', 'upperLimit': '-2.13'}, {'value': '-2.45', 'groupId': 'OG001', 'lowerLimit': '-2.83', 'upperLimit': '-2.06'}, {'value': '-1.70', 'groupId': 'OG002', 'lowerLimit': '-2.11', 'upperLimit': '-1.29'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'OG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}], 'classes': [{'title': 'Change from Baseline at Week 1', 'categories': [{'measurements': [{'value': '-3.82', 'groupId': 'OG000', 'lowerLimit': '-4.52', 'upperLimit': '-3.12'}, {'value': '-4.08', 'groupId': 'OG001', 'lowerLimit': '-4.78', 'upperLimit': '-3.37'}, {'value': '-1.60', 'groupId': 'OG002', 'lowerLimit': '-2.31', 'upperLimit': '-0.89'}]}]}, {'title': 'Change from Baseline at Week 2', 'categories': [{'measurements': [{'value': '-4.10', 'groupId': 'OG000', 'lowerLimit': '-4.83', 'upperLimit': '-3.38'}, {'value': '-4.01', 'groupId': 'OG001', 'lowerLimit': '-4.74', 'upperLimit': '-3.28'}, {'value': '-2.53', 'groupId': 'OG002', 'lowerLimit': '-3.28', 'upperLimit': '-1.78'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Visit and Week 1 Visit, Week 2 Visit', 'description': 'The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants \\>=16 years of age completed the DLQI questionnaire about the condition of their skin over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for DLQI'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'FG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks'}, {'id': 'BG001', 'title': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'spread': '16.3', 'groupId': 'BG000'}, {'value': '40.6', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '39.3', 'spread': '15.2', 'groupId': 'BG002'}, {'value': '39.4', 'spread': '15.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2013-08-02', 'resultsFirstSubmitDate': '2014-10-24', 'studyFirstSubmitQcDate': '2013-08-02', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-10-24', 'studyFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2', 'timeFrame': 'Baseline Visit and Week 2 Visit', 'description': 'The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.'}, {'measure': 'Number of Participants Who Experienced at Least One Adverse Event (AE)', 'timeFrame': 'Up to 4 weeks (Up to 2 weeks after last dose of study drug)', 'description': 'An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.'}, {'measure': 'Number of Participants Who Discontinued Study Drug Due to an AE', 'timeFrame': 'Up to 2 weeks', 'description': 'An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit', 'description': 'The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated.'}, {'measure': 'Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.'}, {'measure': 'Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.'}, {'measure': 'Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved.'}, {'measure': 'Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.'}, {'measure': 'Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated.'}, {'measure': 'Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2', 'timeFrame': 'Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit', 'description': 'Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.'}, {'measure': 'Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2', 'timeFrame': 'Baseline Visit and Week 1 Visit, Week 2 Visit', 'description': 'The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants \\>=16 years of age completed the DLQI questionnaire about the condition of their skin over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urticaria', 'Skin Diseases, Vascular', 'Skin Diseases', 'Hypersensitivity, Immediate', 'Hypersensitivity', 'Immune System Diseases', 'Cholinergic Antagonists', 'Cholinergic Agents', 'Neurotransmitter Agents', 'Histamine H1 Antagonists, Non-Sedating', 'Histamine H1 Antagonists', 'Histamine Antagonists', 'Histamine Agents'], 'conditions': ['Urticaria']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Hide M, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with chronic urticaria: A randomized controlled trial. J Clin Therapeut Med. 2016;32(11):891-903.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11'}]}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic urticaria \\[rash (erythema, wheal) for more than 1 month without any known cause\\]\n* Out-patient\n\nExclusion Criteria:\n\n* Stimulation-induced urticaria \\[physical urticaria (e.g. cold, solar, and heat urticaria), cholinergic urticaria, contact urticaria)\\]\n* Hypersensitivity to antihistamines or ingredients of a study drug'}, 'identificationModule': {'nctId': 'NCT01916967', 'briefTitle': 'An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Phase III Multicentre, Parallel-group, Randomized, Placebo-controlled, Double-blind Clinical Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Chronic Urticaria.', 'orgStudyIdInfo': {'id': '4117-201'}, 'secondaryIdInfos': [{'id': '132243', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desloratadine 5 mg', 'description': 'Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks', 'interventionNames': ['Drug: Desloratadine', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Desloratadine 10 mg', 'description': 'Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks', 'interventionNames': ['Drug: Desloratadine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Desloratadine', 'type': 'DRUG', 'description': 'Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks', 'armGroupLabels': ['Desloratadine 10 mg', 'Desloratadine 5 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets, given orally, once daily in the evening for 2 weeks', 'armGroupLabels': ['Desloratadine 5 mg', 'Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}