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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NAL ER 54 mg 		Participants will undergo a 2-week blinded titration period (twice daily [BID] dosing with one NAL ER once daily [QD] dose and one placebo QD dose) followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) BID for 52 weeks.
  • Drug: NAL ER
    Oral tablets
    Other names:
    • Nalbuphine
  • Drug: Placebo
    Oral tablets
Placebo Comparator
Placebo 		Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 52 weeks.
  • Drug: Placebo
    Oral tablets

Recruiting Locations

Newportnativemd, Inc.
Newport Beach, California 92663-3600

Palmtree Clinical Research
Palm Springs, California 92262

Paradigm Clinical Research Centers, Inc. - Redding
Redding, California 96001

Critical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic
Lakewood, Colorado 80228

Meris Clinical Research
Brandon, Florida 33511

Clinical Research Specialists, Llc - Kissimmee
Kissimmee, Florida 34746-4654

Pulmonary Specialists of The Palm Beaches
Loxahatchee Groves, Florida 33470

Clinical Research and Associates, Inc.
Miami, Florida 33126

Coastal Pulmonary & Critical Care, PLC
St. Petersburg, Florida 33704-2733

Tulane Clinic
New Orleans, Louisiana 70112

Hannibal Regional Hospital
Hannibal, Missouri 63401

Clinical Research of Gastonia (CRG)
Gastonia, North Carolina 28054

Southeastern Research Center
Winston-Salem, North Carolina 27103

Clinical Research Associates of Central, PA, LLC
DuBois, Pennsylvania 15801

Anmed Medical Center
Anderson, South Carolina 29621

Horizon Clinical Research Group
Cypress, Texas 77429

El Paso Pulmonary Association, PA
El Paso, Texas 79902

Elevate Clinical Research
Houston, Texas 77058

Pulmonary Associates of Richmond Inc (Par) - West Broad Location
Richmond, Virginia 23230-1710

More Details

Status
Recruiting
Sponsor
Trevi Therapeutics

Study Contact

Paula Buckley
(203) 304-2499
Paula.Buckley@trevitherapeutics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.