[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659812":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":11,"studyPopulation":11,"armGroups":64,"interventions":77,"overallOfficials":87,"centralContacts":92,"locations":98,"responsibleParty":143,"collaborators":11,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":147,"sex":153,"minAge":154,"maxAge":11,"enrollmentInfo":155,"targetDuration":11,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":11,"overallStatus":101,"whyStopped":11,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Trevi Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo",null,"Baseline, Week 14",[14,16,19,21,23,25,27,30,32,34,36,38,40,42,44,46,48,50,52],{"measure":15,"description":11,"timeFrame":12},"Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 14 for NAL ER Compared With Placebo",{"measure":17,"description":11,"timeFrame":18},"Relative Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo","Baseline, Weeks 6 and 10",{"measure":20,"description":11,"timeFrame":18},"Absolute Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo",{"measure":22,"description":11,"timeFrame":12},"Proportion of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo",{"measure":24,"description":11,"timeFrame":12},"Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 14 for NAL ER Compared With Placebo",{"measure":26,"description":11,"timeFrame":12},"Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms) at Week 14 for NAL ER Compared With Placebo",{"measure":28,"description":11,"timeFrame":29},"Absolute Change from Baseline in the CS-NRS for NAL ER Compared With Placebo","Baseline up to Week 14",{"measure":31,"description":11,"timeFrame":29},"Proportion of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS for NAL ER Compared With Placebo",{"measure":33,"description":11,"timeFrame":12},"Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores at Week 14 for NAL ER Compared With Placebo",{"measure":35,"description":11,"timeFrame":12},"Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social) at Week 14 for NAL ER Compared With 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Cough Score at Week 14 for NAL ER Compared With Placebo",{"measure":49,"description":11,"timeFrame":12},"Proportion of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough at Week 14 for NAL ER Compared With Placebo",{"measure":51,"description":11,"timeFrame":12},"Relative Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) at Week 14 for NAL ER Compared With Placebo",{"measure":53,"description":11,"timeFrame":54},"Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)","Baseline up to Week 17",{"allocation":56,"interventionModel":57,"interventionModelDescription":11,"primaryPurpose":58,"observationalModel":11,"timePerspective":11,"maskingInfo":59},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":60,"maskingDescription":11,"whoMasked":61},"DOUBLE",[62,63],"PARTICIPANT","INVESTIGATOR",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"NAL ER 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304-2499","Paula.Buckley@trevitherapeutics.com",[99,113,123,133],{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":11},"Premier Medical Associates, LLC","RECRUITING","Wilmington","Delaware","19803","United States","US",{"type":108,"coordinates":109},"Point",[110,111],-75.54659,39.74595,{"lat":111,"lon":110},{"facility":114,"status":101,"city":115,"state":116,"zip":117,"country":105,"countryCode":106,"cosmosGeoPoint":118,"geoPoint":122,"contacts":11},"Essential Health and Research Services","North Miami Beach","Florida","33162",{"type":108,"coordinates":119},[120,121],-80.16255,25.93315,{"lat":121,"lon":120},{"facility":124,"status":101,"city":125,"state":126,"zip":127,"country":105,"countryCode":106,"cosmosGeoPoint":128,"geoPoint":132,"contacts":11},"American Health Research - Charlotte Location","Charlotte","North 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Participants With Idiopathic Pulmonary Fibrosis","OCEAN-2","Inclusion Criteria:\n\n* Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS)\u002FJapanese Respiratory Society (JRS)\u002FLatin American Thoracic Society (ALAT) clinical practice guidelines.\n* Chronic cough for ≥8 weeks prior to Screening.\n* PGI-Severity Score ≥ 2 at Screening.\n* Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening.\n* Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening.\n* If currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) should be on a stable dose for at least 6 weeks prior to the Baseline Visit.\n\nExclusion Criteria:\n\n* Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening.\n* Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 8 weeks prior to Screening.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","40 Years",{"count":156,"type":157},201,"ESTIMATED","INTERVENTIONAL",[160],"PHASE3","The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.",[163],"Idiopathic Pulmonary Fibrosis","2026-10-05",{"date":166,"type":167},"2026-10-09","ACTUAL",{"date":169,"type":167},"2026-09-30",{"date":171,"type":157},"2027-10",{"name":5,"class":6},4]