Nalbuphine extended-release tablets for chronic cough in idiopathic pulmonary fibrosis
Tests nalbuphine extended-release tablets for chronic cough in adults with idiopathic pulmonary fibrosis.
Plain-language title generated from the registry record
Registry title: Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets
Key facts
- Where
- Anderson, Brandon, Cypress, DuBois, El Paso, Gastonia, Hannibal, Houston, Kissimmee, Lakewood, Loxahatchee Groves, Miami, Murray, New Orleans, Newport Beach, Palm Springs, Redding, Reno, Richmond, St. Petersburg, The Bronx, and Winston-Salem, United StatesSee the 22 sites
- Phase
- Phase 3
Where in United States
- Anmed Medical CenterAnderson, United StatesTaking people
- Meris Clinical ResearchBrandon, United StatesTaking people
- Horizon Clinical Research GroupCypress, United StatesTaking people
- Clinical Research Associates of Central Pa, LLCDuBois, United StatesTaking people
- El Paso Pulmonary Association, PAEl Paso, United StatesTaking people
- Clinical Research of Gastonia (CRG)Gastonia, United StatesTaking people
- Hannibal Regional HospitalHannibal, United StatesTaking people
- Elevate Clinical ResearchHouston, United StatesTaking people
- Clinical Research Specialists, Llc - KissimmeeKissimmee, United StatesTaking people
- Critical Care Pulmonary and Sleep Associates (Ccpsa) - West ClinicLakewood, United StatesTaking people
- Pulmonary Specialists of the Palm BeachesLoxahatchee Groves, United StatesTaking people
- Clinical Research and Associates, Inc.Miami, United StatesTaking people
- Intermountain MedicalL Center- PulmonaryY and Critical Care ResearchMurray, United StatesTaking people
- Tulane ClinicNew Orleans, United StatesTaking people
- NewportNativeMD, Inc.Newport Beach, United StatesTaking people
- Palmtree Clinical ResearchPalm Springs, United StatesTaking people
- Paradigm Clinical Research Centers, Inc. - ReddingRedding, United StatesTaking people
- Renown Regional Medical Center - Center For Advanced Medicine BReno, United StatesTaking people
- Pulmonary Associates of Richmond Inc (Par) - West Broad LocationRichmond, United StatesTaking people
- Coastal Pulmonary & Critical Care, PLCSt. Petersburg, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- Southeastern Research CenterWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Trevi Therapeutics
- Trial code
- NCT07671911EU 2026-525877-38-00
- Record updated
- 13 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin 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 (nintedanib, pirfenidone, nerandomilast) approved for IPF should be on a stable dose for at least 6 weeks prior to the Baseline Visit.
Exclusion: 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; Note: Other protocol-defined inclusion/exclusion criteria may apply.