A Phase 3 interventional study of NAL ER and Placebo in Idiopathic Pulmonary Fibrosis, sponsored by Trevi Therapeutics. Recruiting at 4 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Trevi Therapeutics · Phase 3, Interventional, and Treatment
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.
565 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's planned enrollment of 201 is above the median of 55 across 388 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Trevi Therapeutics is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
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 12 weeks.
Drug: NAL ER
Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 12 weeks.
Drug: Placebo
Oral tablets
Also known as: Nalbuphine
Oral tablets
Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Relative Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo
Time frame: Baseline, Weeks 6 and 10
Absolute Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo
Time frame: Baseline, Weeks 6 and 10
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
Time frame: Baseline, Week 14
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
Time frame: Baseline, Week 14
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
Time frame: Baseline, Week 14
Absolute Change from Baseline in the CS-NRS for NAL ER Compared With Placebo
Time frame: Baseline up to Week 14
Proportion of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS for NAL ER Compared With Placebo
Time frame: Baseline up to Week 14
Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social) at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Proportion of Participants Achieving a 1.3-point Increase (Improvement) from Baseline in LCQ Total Score at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Relative Change from Baseline in Awake Cough Frequency at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Relative Change from Baseline in Sleep Cough Frequency at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
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
Time frame: Baseline, Week 14
Relative Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Week 17
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Nalbuphine
Idiopathic Pulmonary Fibrosis →