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

Part of paid clinical trials in Loxahatchee Groves, Florida.

Sponsor
Trevi Therapeutics
Study ID
NCT07671911
Phase
PHASE3
Status
Recruiting
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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
Jul 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 followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) twice daily (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 (5)

FacilityCityStateZIPSite coordinators
Pulmonary Specialists of The Palm BeachesLoxahatchee GrovesFlorida33470-
Clinical Research and Associates, Inc.MiamiFlorida33126-
Clinical Research of Gastonia (CRG)GastoniaNorth Carolina28054-
El Paso Pulmonary Association, PAEl PasoTexas79902-
Elevate Clinical ResearchHoustonTexas77058-

Find similar trials in Loxahatchee Groves, FL

By research site
Pulmonary Specialists of The Palm Beaches· Loxahatchee Groves, FLClinical Research and Associates, Inc.· Miami, FLClinical Research of Gastonia (CRG)· Gastonia, NCEl Paso Pulmonary Association, PA· El Paso, TXElevate Clinical Research· Houston, TX

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