Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT03569033
Status:
TERMINATED
Last Update Posted:
2019-12-10
First Post:
2018-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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 Corp.'}, 'certainAgreement': {'otherDetails': 'The sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the sponsor, 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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated because the data did not support study endpoints for acute cough, based on an interim efficacy analysis; not due to safety concerns.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 21 days', 'description': 'All randomized participants who received at least 1 dose of study treatment', 'eventGroups': [{'id': 'EG000', 'title': 'MK-7264 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet BID for 7 days.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received a matching placebo tablet BID for 7 days.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 22, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Medical device site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Awake Coughs Per Hour on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.'}, {'id': 'OG001', 'title': 'Placebo BID', 'description': 'Participants received a matching placebo tablet BID for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'groupId': 'OG000', 'lowerLimit': '1.01', 'upperLimit': '3.75'}, {'value': '2.70', 'groupId': 'OG001', 'lowerLimit': '1.21', 'upperLimit': '4.19'}]}]}], 'analyses': [{'pValue': '0.748', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-2.29', 'ciUpperLimit': '1.66', 'statisticalMethod': 'Longitudinal Data Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 3', 'description': 'Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.', 'unitOfMeasure': 'Coughs per hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with human rhinovirus type 16 (HRV-16)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.'}, {'id': 'OG001', 'title': 'Placebo BID', 'description': 'Participants received a matching placebo tablet BID for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.07', 'groupId': 'OG000', 'lowerLimit': '1.79', 'upperLimit': '10.35'}, {'value': '5.08', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '9.78'}]}]}], 'analyses': [{'pValue': '0.754', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '-5.33', 'ciUpperLimit': '7.30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3', 'description': 'The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.'}, {'id': 'OG001', 'title': 'Placebo BID', 'description': 'Participants received a matching placebo tablet BID for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.71', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '4.97'}, {'value': '1.91', 'groupId': 'OG001', 'lowerLimit': '-0.55', 'upperLimit': '4.38'}]}]}], 'analyses': [{'pValue': '0.627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '-2.50', 'ciUpperLimit': '4.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3', 'description': 'The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.'}, {'id': 'OG001', 'title': 'Placebo BID', 'description': 'Participants received a matching placebo tablet BID for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'groupId': 'OG000', 'lowerLimit': '-0.51', 'upperLimit': '-0.01'}, {'value': '-0.35', 'groupId': 'OG001', 'lowerLimit': '-0.62', 'upperLimit': '-0.08'}]}]}], 'analyses': [{'pValue': '0.631', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.45', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3', 'description': "The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced One or More Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.'}, {'id': 'OG001', 'title': 'Placebo BID', 'description': 'Participants received a matching placebo tablet BID for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '95.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21 days', 'description': 'An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.'}, {'id': 'OG001', 'title': 'Placebo BID', 'description': 'Participants received a matching placebo tablet BID for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 7', 'description': 'An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.'}, {'id': 'FG001', 'title': 'Placebo BID', 'description': 'Participants received a matching placebo tablet BID for 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.'}, {'id': 'BG001', 'title': 'Placebo BID', 'description': 'Participants received a matching placebo tablet BID for 7 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '24.3', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '24.6', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-13', 'size': 904207, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-28T10:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'whyStopped': 'The data did not support study endpoints for acute cough, based on an interim efficacy analysis; not due to safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2018-06-14', 'resultsFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-25', 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Awake Coughs Per Hour on Day 3', 'timeFrame': 'Day 3', 'description': 'Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3', 'timeFrame': 'Baseline and Day 3', 'description': 'The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3.'}, {'measure': 'Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3', 'timeFrame': 'Baseline and Day 3', 'description': 'The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3.'}, {'measure': 'Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3', 'timeFrame': 'Baseline and Day 3', 'description': "The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3."}, {'measure': 'Percentage of Participants Who Experienced One or More Adverse Events (AEs)', 'timeFrame': 'Up to 21 days', 'description': 'An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.'}, {'measure': 'Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)', 'timeFrame': 'Up to Day 7', 'description': 'An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Cough']}, 'referencesModule': {'references': [{'pmid': '35969360', 'type': 'DERIVED', 'citation': 'Smith JA, Kitt MM, Bell A, Noulin N, Tzontcheva A, Seng MM, Lu S. Treatment with the P2X3-Receptor Antagonist Gefapixant for Acute Cough in Induced Viral Upper Respiratory Tract Infection: A Phase 2a, Randomized, Placebo-Controlled Trial. Pulm Ther. 2022 Sep;8(3):297-310. doi: 10.1007/s41030-022-00193-w. Epub 2022 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In good general health\n* Susceptible to human rhinovirus type 16 (HRV-16)\n* Male or non-pregnant and non-breast feeding female\n* If female of reproductive potential, agrees to use 1 form of acceptable birth control\n\nExclusion Criteria:\n\n* Donated blood within 56 days or donated plasma within 7 days prior to dosing\n* History of significant multiple and/or severe allergies\n* Recent history of respiratory tract infection\n* History of cancer\n* Body mass index \\<18 kg/m\\^2 or ≥40 kg/m\\^2\n* History of major surgery or loss of 1 unit of blood\n* History of allergic reaction to sulfonamides\n* Received medications within 14 days prior to randomization\n* Significantly abnormal laboratory tests at Screening\n* Current smoker, smoked within 5 years of Screening, or significant past smoking history\n* History of alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT03569033', 'briefTitle': 'Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants With Induced Viral Upper Respiratory Tract Infection', 'orgStudyIdInfo': {'id': '7264-013'}, 'secondaryIdInfos': [{'id': 'MK-7264-013', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': '2017-000472-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gefapixant 45 mg BID', 'description': 'Participants will receive a gefapixant 45 mg tablet twice daily (BID) for 7 days.', 'interventionNames': ['Drug: Gefapixant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo BID', 'description': 'Participants will receive a matching placebo tablet BID for 7 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Gefapixant', 'type': 'DRUG', 'otherNames': ['MK-7264'], 'description': 'Gefapixant 45 mg will be administered orally.', 'armGroupLabels': ['Gefapixant 45 mg BID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet matching gefapixant will be administered orally.', 'armGroupLabels': ['Placebo BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 2AX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}