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

Part of paid clinical trials in Newport Beach, California.

Sponsor
Trevi Therapeutics
Study ID
NCT07671911
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NAL ER — DRUG
    Oral tablets
  • Placebo — DRUG
    Oral tablets

Study Details

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).

Key Dates

First listed
Jun 26, 2026
Start date
Jun 29, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
306 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Relative Change from Baseline in 24-hour Cough Frequency at Week 26 [ Time Frame: Baseline, Week 26 ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Newportnativemd, Inc.Newport BeachCalifornia92663-3600-
Palmtree Clinical ResearchPalm SpringsCalifornia92262-
Paradigm Clinical Research Centers, Inc. - ReddingReddingCalifornia96001-
Critical Care Pulmonary and Sleep Associates (Ccpsa) - West ClinicLakewoodColorado80228-
Meris Clinical ResearchBrandonFlorida33511-
Clinical Research Specialists, Llc - KissimmeeKissimmeeFlorida34746-4654-
Pulmonary Specialists of The Palm BeachesLoxahatchee GrovesFlorida33470-
Clinical Research and Associates, Inc.MiamiFlorida33126-
Coastal Pulmonary & Critical Care, PLCSt. PetersburgFlorida33704-2733-
Tulane ClinicNew OrleansLouisiana70112-
Hannibal Regional HospitalHannibalMissouri63401-
Clinical Research of Gastonia (CRG)GastoniaNorth Carolina28054-
Southeastern Research CenterWinston-SalemNorth Carolina27103-
Clinical Research Associates of Central, PA, LLCDuBoisPennsylvania15801-
Anmed Medical CenterAndersonSouth Carolina29621-
Horizon Clinical Research GroupCypressTexas77429-
El Paso Pulmonary Association, PAEl PasoTexas79902-
Elevate Clinical ResearchHoustonTexas77058-
Pulmonary Associates of Richmond Inc (Par) - West Broad LocationRichmondVirginia23230-1710-

Find similar trials in Newport Beach, CA

By research site
Newportnativemd, Inc.· Newport Beach, CAPalmtree Clinical Research· Palm Springs, CAParadigm Clinical Research Centers, Inc. - Redding· Redding, CACritical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic· Lakewood, COMeris Clinical Research· Brandon, FLClinical Research Specialists, Llc - Kissimmee· Kissimmee, FL

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