Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT04193202
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2019-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096822', 'term': 'Chronic Cough'}, {'id': 'D003371', 'term': 'Cough'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597312', 'term': 'Gefapixant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 114 days', 'description': 'All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.', 'eventGroups': [{'id': 'EG000', 'title': 'Gefapixant', 'description': 'Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.', 'otherNumAtRisk': 206, 'deathsNumAtRisk': 208, 'otherNumAffected': 105, 'seriousNumAtRisk': 206, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 211, 'otherNumAffected': 22, 'seriousNumAtRisk': 209, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Ageusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 70, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tonsillar cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gefapixant', 'description': 'Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.34', 'groupId': 'OG000', 'lowerLimit': '3.84', 'upperLimit': '4.83'}, {'value': '3.59', 'groupId': 'OG001', 'lowerLimit': '3.09', 'upperLimit': '4.09'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.06', 'ciUpperLimit': '1.44', 'estimateComment': 'The estimated difference is the treatment difference in model based mean change from baseline at Week 12', 'statisticalMethod': 'Longitudinal ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline LCQ total score.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have taken at least one dose of study intervention, and had LCQ total score values at both baseline and week 12. Participants were analyzed in the group as randomized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gefapixant', 'description': 'Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.79', 'groupId': 'OG000', 'lowerLimit': '-35.37', 'upperLimit': '-28.20'}, {'value': '-24.87', 'groupId': 'OG001', 'lowerLimit': '-28.41', 'upperLimit': '-21.32'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.92', 'ciLowerLimit': '-11.88', 'ciUpperLimit': '-1.97', 'pValueComment': 'Nominal p value, not controlled for multiplicity', 'estimateComment': 'The estimated difference is the treatment difference in model based mean change from baseline at Week 12.', 'statisticalMethod': 'Longitudinal ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline mean weekly cough severity VAS score.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score is calculated.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have taken at least one dose of study intervention, and had VAS total score values at both baseline and week 12. Participants were analyzed in the group as randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With One or More Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gefapixant', 'description': 'Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000'}, {'value': '43.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 14 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Discontinue Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gefapixant', 'description': 'Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 12 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gefapixant', 'description': 'Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '211'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '209'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '201'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gefapixant', 'description': 'Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52.6', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '52.5', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Leicester Cough Questionnaire (LCQ)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '11.3', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '11.0', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The LCQ is a 19-item, cough-specific health related qualify of life (HRQoL) questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Includes randomized participants who had LCQ total score values at baseline'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-25', 'size': 1645513, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-19T13:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 419}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2019-12-09', 'resultsFirstSubmitDate': '2022-09-19', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-19', 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score is calculated.'}, {'measure': 'Percentage of Participants With One or More Adverse Events (AEs)', 'timeFrame': 'Up to approximately 14 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs is presented.'}, {'measure': 'Percentage of Participants Who Discontinue Study Drug Due to an AE', 'timeFrame': 'Up to approximately 12 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE is presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cough', 'Respiration disorders', 'Respiratory tract diseases', 'Signs and symptoms, respiratory', 'Signs and symptoms'], 'conditions': ['Chronic Cough']}, 'referencesModule': {'references': [{'pmid': '36879087', 'type': 'RESULT', 'citation': 'McGarvey L, Sher M, Shvarts YG, Lu S, Wu WC, Xu P, Schelfhout J, La Rosa C, Nguyen AM, Reyfman PA, Afzal AS. The Efficacy and Safety of Gefapixant in a Phase 3b Trial of Patients with Recent-Onset Chronic Cough. Lung. 2023 Apr;201(2):111-118. doi: 10.1007/s00408-023-00606-w. Epub 2023 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration \\>8 weeks after onset of cough symptoms) for \\<12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chest radiograph or CT thorax (within 1 year of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease, in the opinion of the principal investigator or the subinvestigator\n* Has chronic cough (defined as duration of \\>8 weeks after onset of cough symptoms) for \\<12 months prior to the screening visit (\\<14 months after onset of cough symptoms)\n* Has a diagnosis of refractory chronic cough or unexplained chronic cough\n* Female participants are not pregnant, not breastfeeding, not of childbearing potential, or agree to follow contraceptive guidance\n\nExclusion Criteria:\n\n* Is a current smoker\n* Has given up smoking within 12 months of screening\n* Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)\n* Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening\n* Has a history of chronic bronchitis, defined as cough that produces \\>1 tablespoon of phlegm, that occurs every day for at least 3 months in a row\n* Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or cervical cancer\n* Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse\n* Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide-containing drugs\n* Has a known allergy to gefapixant 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