201 Participants NeededMy employer runs this trial

Nalbuphine for Idiopathic Pulmonary Fibrosis

(OCEAN-2 Trial)

Recruiting at 3 trial locations
PB
Overseen ByPaula Buckley
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Trevi Therapeutics
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.

Who Is on the Research Team?

CD

Chief Development Officer

Principal Investigator

Trevi Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with idiopathic pulmonary fibrosis (IPF) who have a persistent, chronic cough. People with other major lung diseases or health issues that could interfere with the study may not be able to join.

Inclusion Criteria

PGI-Severity Score ≥ 2 at Screening
Forced vital capacity (FVC) ≥40% of predicted at Screening
I have had a cough lasting at least 8 weeks.
See 3 more

Exclusion Criteria

I have had symptoms of a respiratory infection in the past 8 weeks.
I have not been hospitalized for a lung illness in the past 8 weeks.

What Are the Treatments Tested in This Trial?

Interventions

  • Nalbuphine Extended-Release (NAL ER)

Trial Overview

The study tests whether extended-release nalbuphine (NAL ER) tablets can safely and effectively reduce chronic cough in people with IPF, compared to a placebo. Participants are randomly assigned to receive either NAL ER or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NAL ER 54 mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Trevi Therapeutics

Lead Sponsor

Trials
11
Recruited
1,400+