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Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets

RecruitingPhase 3

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

Who can join

Ages 40 and older · All sexes

Full eligibility criteria
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.

About the study

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).

What is being tested

Sponsor: Trevi Therapeutics · Participants: 306 · Started: Jun 29, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07671911

Locations in the U.S.

CaliforniaNewportnativemd, Inc., Newport Beach
Palmtree Clinical Research, Palm Springs
Paradigm Clinical Research Centers, Inc. - Redding, Redding
ColoradoCritical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic, Lakewood
FloridaMeris Clinical Research, Brandon
Clinical Research Specialists, Llc - Kissimmee, Kissimmee
Pulmonary Specialists of The Palm Beaches, Loxahatchee Groves
Clinical Research and Associates, Inc., Miami
Coastal Pulmonary & Critical Care, PLC, St. Petersburg
LouisianaTulane Clinic, New Orleans
MissouriHannibal Regional Hospital, Hannibal
North CarolinaClinical Research of Gastonia (CRG), Gastonia
Southeastern Research Center, Winston-Salem
PennsylvaniaClinical Research Associates of Central, PA, LLC, DuBois
South CarolinaAnmed Medical Center, Anderson
TexasHorizon Clinical Research Group, Cypress
El Paso Pulmonary Association, PA, El Paso
Elevate Clinical Research, Houston
VirginiaPulmonary Associates of Richmond Inc (Par) - West Broad Location, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.