[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07671911":3,"trial-entities:NCT07671911":163,"trial-summary:NCT07671911":166},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":44,"sex":92,"minimum_age":93,"maximum_age":17,"healthy_volunteers":94,"eligibility_criteria":95,"std_ages":108,"locations":111,"central_contacts":151,"overall_officials":157,"references":161,"see_also_links":162},"NCT07671911","NAL03-301","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","RECRUITING","2028-07","2026-07","2026-07-10","2026-06-29","Trevi Therapeutics","INDUSTRY",true,"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).",null,[19],"Idiopathic Pulmonary Fibrosis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},306,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","NAL ER","Oral tablets",[34],"NAL ER 54 mg",[36],"Nalbuphine",{"type":30,"name":38,"description":32,"armGroupLabels":39},"Placebo",[38],[41],{"measure":42,"timeFrame":43},"Relative Change from Baseline in 24-hour Cough Frequency at Week 26","Baseline, Week 26",[45,47,50,52,54,56,58,61,63,65,67,69,71,73,75,77,79,81,83,85,87,89],{"measure":46,"timeFrame":43},"Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26",{"measure":48,"timeFrame":49},"Relative Change from Baseline in 24-hour Cough Frequency at Week 6","Baseline, Week 6",{"measure":51,"timeFrame":43},"Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26",{"measure":53,"timeFrame":43},"Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26",{"measure":55,"timeFrame":43},"Percentage of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS at Week 26",{"measure":57,"timeFrame":43},"Absolute Change from Baseline in the E:RS IPF Breathlessness Domain at Week 26",{"measure":59,"timeFrame":60},"Relative Change from Baseline in 24-hour Cough Frequency","Baseline up to Week 54",{"measure":62,"timeFrame":60},"Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-Hour Cough Frequency",{"measure":64,"timeFrame":60},"Absolute Change from Baseline in the E-RS:IPF Cough Domain",{"measure":66,"timeFrame":60},"Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms)",{"measure":68,"timeFrame":60},"Absolute Change from Baseline in the CS-NRS",{"measure":70,"timeFrame":60},"Percentage of Participants Achieving a ≥3-Point Improvement from Baseline in CS-NRS",{"measure":72,"timeFrame":60},"Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores",{"measure":74,"timeFrame":60},"Percentage of Participants Achieving a 1.3-Point Increase (Improvement) from Baseline in LCQ Total Score",{"measure":76,"timeFrame":60},"Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social)",{"measure":78,"timeFrame":43},"Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 26",{"measure":80,"timeFrame":60},"Relative Change from Baseline in Awake Cough Frequency",{"measure":82,"timeFrame":60},"Relative Change from Baseline in Sleep Cough Frequency",{"measure":84,"timeFrame":60},"Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score",{"measure":86,"timeFrame":60},"Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score",{"measure":88,"timeFrame":60},"Percentage of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough",{"measure":90,"timeFrame":91},"Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)","Up to Week 57","ALL","40 Years",false,{"inclusion":96,"exclusion":103,"raw_text":107},[97,98,99,100,101,102],"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.","Chronic cough for ≥8 weeks prior to Screening.","PGI-Severity Score ≥ 2 at Screening.","Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening.","Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening.","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.",[104,105,106],"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.","Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 2 months prior to Screening.","Diagnosed sleep apnea or currently on any treatment for sleep apnea \\[example (e.g.), Continuous Positive Airway Pressure (CPAP)\\].","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.",[109,110],"ADULT","OLDER_ADULT",[112,121,128,136,144],{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":117,"geoPoint":118},"Pulmonary Specialists of The Palm Beaches","Loxahatchee Groves","Florida","33470","United States",{"lat":119,"lon":120},26.68368,-80.27977,{"facility":122,"status":8,"city":123,"state":115,"zip":124,"country":117,"geoPoint":125},"Clinical Research and Associates, Inc.","Miami","33126",{"lat":126,"lon":127},25.77427,-80.19366,{"facility":129,"status":8,"city":130,"state":131,"zip":132,"country":117,"geoPoint":133},"Clinical Research of Gastonia (CRG)","Gastonia","North Carolina","28054",{"lat":134,"lon":135},35.26208,-81.1873,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":117,"geoPoint":141},"El Paso Pulmonary Association, PA","El Paso","Texas","79902",{"lat":142,"lon":143},31.75872,-106.48693,{"facility":145,"status":8,"city":146,"state":139,"zip":147,"country":117,"geoPoint":148},"Elevate Clinical Research","Houston","77058",{"lat":149,"lon":150},29.76328,-95.36327,[152],{"name":153,"role":154,"phone":155,"email":156},"Paula Buckley","CONTACT","(203) 304-2499","Paula.Buckley@trevitherapeutics.com",[158],{"name":159,"affiliation":13,"role":160},"Chief Development Officer","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":164,"biomarkers":165},[19],[],{"nct_id":4,"found":15,"summary":167,"prompt_version":177},{"design":168,"status":169,"heading":170,"summary":171,"follow_up":172,"word_count":173,"commitments":174,"compensation":175,"drugs_mentioned":176},"This interventional study will compare NAL ER oral tablets to a placebo (an inactive pill) in about 306 participants.","completed","NAL ER for Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough","This study is looking into whether NAL ER tablets can help reduce chronic cough in people with Idiopathic Pulmonary Fibrosis (IPF). IPF is a lung disease that causes scarring of the lungs. Researchers want to see if NAL ER is safe and effective for this type of cough. You might be able to join if you are 40 years or older, have been diagnosed with IPF by a doctor, and have had a chronic cough for at least 8 weeks. The main goal is to see how much your 24-hour cough frequency changes after 26 weeks of treatment. The study is currently unclear on its recruitment status and plans to enroll about 306 participants.","Your cough frequency will be measured at the beginning of the study and again at Week 26.",114,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]