NCT07868419RecruitingPhase 3
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets
A Randomized, Double-Blind, Placebo-Controlled Twelve-Week Fixed-Dose Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 201 (estimated)
- First submitted
- 5 Oct 2026
- Start date
- 30 Sept 2026
- Primary completion date
- Aug 2027
- Lead sponsor
- Trevi Therapeutics
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT07868419
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 201
- From 30 Sept 2026 to the primary completion date, Aug 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 8 weeks prior to Screening.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Who the study is looking for
- 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.
- If currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) should be on a stable dose for at least 6 weeks prior to the Baseline Visit.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| American Health Research - Charlotte Location Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Essential Health and Research Services Coordinator of this site? Confirm its status | North Miami Beach | United States | Recruiting |
| Hillcroft Medical Clinic Coordinator of this site? Confirm its status | Sugar Land | United States | Recruiting |
| Premier Medical Associates, LLC Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.