Clinical Trials in the USA / NCT07868419
Recruiting
Phase 3
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets
NCT07868419 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Idiopathic Pulmonary Fibrosis
Investigational drug(s) / intervention(s)
NAL ER →Placebo
NAL ER: Oral tablets
Placebo: Oral tablets
Study summary
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo — Baseline, Week 14
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Premier Medical Associates, LLC | Wilmington | Delaware | Recruiting |
| Essential Health and Research Services | North Miami Beach | Florida | Recruiting |
| American Health Research - Charlotte Location | Charlotte | North Carolina | Recruiting |
| Hillcroft Medical Clinic | Sugar Land | Texas | Recruiting |
More Trevi Therapeutics trials in the USA
Other trials for the same condition
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Active, not recruiting
A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07868419 on ClinicalTrials.gov ↗ ← All trials in the USA