Idiopathic Pulmonary FibrosisPhase 3OCEAN-2NCT07868419
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets
A Phase 3 study testing NAL ER in people with Idiopathic Pulmonary Fibrosis, run by Trevi Therapeutics at 4 sites in United States.
Trial summary
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- NAL ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Sep 2026to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- If currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) should be on a stable dose for at least 6 weeks prior to the Baseline Visit.
Who cannot join
- 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 8 weeks prior to Screening.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
American Health Research - Charlotte Location
Charlotte, North Carolina, 28277
- Recruiting
Essential Health and Research Services
North Miami Beach, Florida, 33162
- Recruiting
Hillcroft Medical Clinic
Sugar Land, Texas, 77478
- Recruiting
Premier Medical Associates, LLC
Wilmington, Delaware, 19803
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Twelve-Week Fixed-Dose Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- NAL ER, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAL ERDrug
Also called Nalbuphine
Oral tablets
PlaceboDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| NAL ER 54 mg | Experimental | 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 12 weeks. Receives: Drug: NAL ER |
| Placebo | Placebo comparator | Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Secondary outcomes (19)
Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Relative Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo
Measured: Baseline, Weeks 6 and 10
Absolute Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo
Measured: Baseline, Weeks 6 and 10
Proportion of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms) at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Absolute Change from Baseline in the CS-NRS for NAL ER Compared With Placebo
Measured: Baseline up to Week 14
Proportion of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS for NAL ER Compared With Placebo
Measured: Baseline up to Week 14
Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social) at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Proportion of Participants Achieving a 1.3-point Increase (Improvement) from Baseline in LCQ Total Score at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Relative Change from Baseline in Awake Cough Frequency at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Relative Change from Baseline in Sleep Cough Frequency at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Proportion of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Relative Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) at Week 14 for NAL ER Compared With Placebo
Measured: Baseline, Week 14
Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline up to Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start30 Sep 2026
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trevi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Development Officer, Study director, Trevi Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868419
- Sponsor's protocol ID
- NAL03-302
- Acronym
- OCEAN-2
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Twelve-Week Fixed-Dose Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07868419
- Acronym / sponsor ID
- OCEAN-2 / NAL03-302
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Trevi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAL ER 54 mg | Experimental | Drug: NAL ERParticipants 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 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 8 weeks prior to Screening.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAL ERAlso: NalbuphineOral tablets | Drug | NAL ER 54 mg |
| PlaceboOral tablets | Drug | Placebo |
Primary outcome
Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
19 secondary outcomes
Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Relative Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo
Time frame: Baseline, Weeks 6 and 10
Absolute Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo
Time frame: Baseline, Weeks 6 and 10
Proportion of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms) at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Absolute Change from Baseline in the CS-NRS for NAL ER Compared With Placebo
Time frame: Baseline up to Week 14
Proportion of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS for NAL ER Compared With Placebo
Time frame: Baseline up to Week 14
Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social) at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Proportion of Participants Achieving a 1.3-point Increase (Improvement) from Baseline in LCQ Total Score at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Relative Change from Baseline in Awake Cough Frequency at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Relative Change from Baseline in Sleep Cough Frequency at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Proportion of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Relative Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) at Week 14 for NAL ER Compared With Placebo
Time frame: Baseline, Week 14
Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Week 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chief Development Officer study director
Trevi Therapeutics, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NAL ER in people with Idiopathic Pulmonary Fibrosis, run by Trevi Therapeutics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula Buckley ((203) 304-2499, Paula.Buckley@trevitherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo (time frame: Baseline, Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.