[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644504":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":94,"collaborators":30,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":30,"enrollmentInfo":106,"targetDuration":30,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":30,"overallStatus":44,"whyStopped":30,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Trevi Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NAL ER 54 mg","EXPERIMENTAL","Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) twice daily (BID) for 52 weeks.",[13],"Drug: NAL ER",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 52 weeks.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","NAL ER","Oral tablets",[9],[27],"Nalbuphine",{"type":22,"name":15,"description":24,"armGroupLabels":29,"otherNames":30},[15],null,[32],{"name":33,"affiliation":5,"role":34},"Chief Development Officer","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Paula Buckley","CONTACT","(203) 304-2499","Paula.Buckley@trevitherapeutics.com",[42,56,65,75,85],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":30},"Pulmonary Specialists of The Palm Beaches","RECRUITING","Loxahatchee Groves","Florida","33470","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-80.27977,26.68368,{"lat":54,"lon":53},{"facility":57,"status":44,"city":58,"state":46,"zip":59,"country":48,"countryCode":49,"cosmosGeoPoint":60,"geoPoint":64,"contacts":30},"Clinical Research and Associates, Inc.","Miami","33126",{"type":51,"coordinates":61},[62,63],-80.19366,25.77427,{"lat":63,"lon":62},{"facility":66,"status":44,"city":67,"state":68,"zip":69,"country":48,"countryCode":49,"cosmosGeoPoint":70,"geoPoint":74,"contacts":30},"Clinical Research of Gastonia (CRG)","Gastonia","North Carolina","28054",{"type":51,"coordinates":71},[72,73],-81.1873,35.26208,{"lat":73,"lon":72},{"facility":76,"status":44,"city":77,"state":78,"zip":79,"country":48,"countryCode":49,"cosmosGeoPoint":80,"geoPoint":84,"contacts":30},"El Paso Pulmonary Association, PA","El Paso","Texas","79902",{"type":51,"coordinates":81},[82,83],-106.48693,31.75872,{"lat":83,"lon":82},{"facility":86,"status":44,"city":87,"state":78,"zip":88,"country":48,"countryCode":49,"cosmosGeoPoint":89,"geoPoint":93,"contacts":30},"Elevate Clinical Research","Houston","77058",{"type":51,"coordinates":90},[91,92],-95.36327,29.76328,{"lat":92,"lon":91},{"type":95,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100644504","phase-3-idiopathic-pulmonary-fibrosis-ipf-related-chronic-cough-reduction-with-nalbuphine-extended-release-nal-er-tablets-100644504",false,"NCT07671911","Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis","OCEAN-1","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* Participants who are currently taking antifibrotic medication (e.g., 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 2 months prior to Screening.\n* Diagnosed sleep apnea or currently on any treatment for sleep apnea \\[example (e.g.), Continuous Positive Airway Pressure (CPAP)\\].\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","40 Years",{"count":107,"type":108},306,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with Idiopathic Pulmonary Fibrosis (IPF).",[114],"Idiopathic Pulmonary Fibrosis","2026-07-09",{"date":117,"type":118},"2026-07-10","ACTUAL",{"date":120,"type":118},"2026-06-29",{"date":122,"type":108},"2028-07",{"name":5,"class":6},5]