Clinical Trials in the USA / NCT07671911
Recruiting
Phase 3
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets
NCT07671911 · 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 Idiopathic Pulmonary Fibrosis (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.
* 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 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 2 months 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 26 — Baseline, Week 26
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| Newportnativemd, Inc. | Newport Beach | California | Recruiting |
| Palmtree Clinical Research | Palm Springs | California | Recruiting |
| Paradigm Clinical Research Centers, Inc. - Redding | Redding | California | Recruiting |
| Critical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic | Lakewood | Colorado | Recruiting |
| Meris Clinical Research | Brandon | Florida | Recruiting |
| Clinical Research Specialists, Llc - Kissimmee | Kissimmee | Florida | Recruiting |
| Pulmonary Specialists of The Palm Beaches | Loxahatchee Groves | Florida | Recruiting |
| Clinical Research and Associates, Inc. | Miami | Florida | Recruiting |
| Coastal Pulmonary & Critical Care, PLC | St. Petersburg | Florida | Recruiting |
| Tulane Clinic | New Orleans | Louisiana | Recruiting |
| Hannibal Regional Hospital | Hannibal | Missouri | Recruiting |
| Renown Regional Medical Center - Center For Advanced Medicine B | Reno | Nevada | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
| Clinical Research of Gastonia (CRG) | Gastonia | North Carolina | Recruiting |
| Southeastern Research Center | Winston-Salem | North Carolina | Recruiting |
| Clinical Research Associates of Central, PA, LLC | DuBois | Pennsylvania | Recruiting |
| Anmed Medical Center | Anderson | South Carolina | Recruiting |
| Horizon Clinical Research Group | Cypress | Texas | Recruiting |
| El Paso Pulmonary Association, PA | El Paso | Texas | Recruiting |
| Elevate Clinical Research | Houston | Texas | Recruiting |
| Intermountain MedicalL Center- PulmonaryY and Critical Care Research | Murray | Utah | Recruiting |
| Pulmonary Associates of Richmond Inc (Par) - West Broad Location | Richmond | Virginia | Recruiting |
More Trevi Therapeutics trials in the USA
Other trials for the same condition
WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Active, not recruiting
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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 NCT07671911 on ClinicalTrials.gov ↗ ← All trials in the USA