[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644504":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":30,"responsibleParty":41,"collaborators":30,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":30,"enrollmentInfo":53,"targetDuration":30,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":30,"overallStatus":62,"whyStopped":30,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":30},{"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",{"type":42,"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":54,"type":55},306,"ESTIMATED","INTERVENTIONAL",[58],"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).",[61],"Idiopathic Pulmonary Fibrosis","NOT_YET_RECRUITING","2026-06-22",{"date":65,"type":66},"2026-06-26","ACTUAL",{"date":68,"type":55},"2026-06",{"date":70,"type":55},"2028-07",{"name":5,"class":6}]