Idiopathic Pulmonary FibrosisPhase 3OCEAN-1NCT07671911
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets
A Phase 3 study testing NAL ER in people with Idiopathic Pulmonary Fibrosis, run by Trevi Therapeutics at 22 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 Idiopathic Pulmonary Fibrosis (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
- 306 participants
- Where
- 22 sitesUnited States
- Study dates
- 29 Jun 2026to Jul 2028
- 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.
- 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.
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 2 months prior to Screening.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 recruiting
- Recruiting
Anmed Medical Center
Anderson, South Carolina, 29621
- Recruiting
Meris Clinical Research
Brandon, Florida, 33511
- Recruiting
Horizon Clinical Research Group
Cypress, Texas, 77429
- Recruiting
Clinical Research Associates of Central, PA, LLC
DuBois, Pennsylvania, 15801
- Recruiting
El Paso Pulmonary Association, PA
El Paso, Texas, 79902
- Recruiting
Clinical Research of Gastonia (CRG)
Gastonia, North Carolina, 28054
- Recruiting
Hannibal Regional Hospital
Hannibal, Missouri, 63401
- Recruiting
Elevate Clinical Research
Houston, Texas, 77058
- Recruiting
Clinical Research Specialists, Llc - Kissimmee
Kissimmee, Florida, 34746-4654
- Recruiting
Critical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic
Lakewood, Colorado, 80228
- Recruiting
Pulmonary Specialists of The Palm Beaches
Loxahatchee Groves, Florida, 33470
- Recruiting
Clinical Research and Associates, Inc.
Miami, Florida, 33126
- Recruiting
Intermountain MedicalL Center- PulmonaryY and Critical Care Research
Murray, Utah, 84107
- Recruiting
Tulane Clinic
New Orleans, Louisiana, 70112
- Recruiting
Newportnativemd, Inc.
Newport Beach, California, 92663-3600
- Recruiting
Palmtree Clinical Research
Palm Springs, California, 92262
- Recruiting
Paradigm Clinical Research Centers, Inc. - Redding
Redding, California, 96001
- Recruiting
Renown Regional Medical Center - Center For Advanced Medicine B
Reno, Nevada, 89502
- Recruiting
Pulmonary Associates of Richmond Inc (Par) - West Broad Location
Richmond, Virginia, 23230-1710
- Recruiting
Coastal Pulmonary & Critical Care, PLC
St. Petersburg, Florida, 33704-2733
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467-2401
- Recruiting
Southeastern Research Center
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled 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 Idiopathic Pulmonary Fibrosis (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 (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. Receives: Drug: NAL ER; Drug: Placebo |
| 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 52 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 26
Measured: Baseline, Week 26
Secondary outcomes (23)
Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26
Measured: Baseline, Week 26
Relative Change from Baseline in 24-hour Cough Frequency at Week 6
Measured: Baseline, Week 6
Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26
Measured: Baseline, Week 26
Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26
Measured: Baseline, Week 26
Percentage of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS at Week 26
Measured: Baseline, Week 26
Absolute Change from Baseline in the E:RS IPF Breathlessness Domain at Week 26
Measured: Baseline, Week 26
Relative Change from Baseline in 24-hour Cough Frequency
Measured: Baseline up to Week 54
Absolute Change from Baseline in 24-hour Cough Frequency
Measured: Baseline up to Week 54
Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-Hour Cough Frequency
Measured: Baseline up to Week 54
Absolute Change from Baseline in the E-RS:IPF Cough Domain
Measured: Baseline up to Week 54
Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms)
Measured: Baseline up to Week 54
Absolute Change from Baseline in the CS-NRS
Measured: Baseline up to Week 54
Percentage of Participants Achieving a ≥3-Point Improvement from Baseline in CS-NRS
Measured: Baseline up to Week 54
Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores
Measured: Baseline up to Week 54
Percentage of Participants Achieving a 1.3-Point Increase (Improvement) from Baseline in LCQ Total Score
Measured: Baseline up to Week 54
Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social)
Measured: Baseline up to Week 54
Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 26
Measured: Baseline, Week 26
Relative Change from Baseline in Awake Cough Frequency
Measured: Baseline up to Week 54
Relative Change from Baseline in Sleep Cough Frequency
Measured: Baseline up to Week 54
Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score
Measured: Baseline up to Week 54
Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score
Measured: Baseline up to Week 54
Percentage of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough
Measured: Baseline up to Week 54
Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Week 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start29 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (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
- 306 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671911
- Sponsor's protocol ID
- NAL03-301
- Other IDs
- 2026-525877-38-00
- Acronym
- OCEAN-1
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 13 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled 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
- NCT07671911
- Acronym / sponsor ID
- OCEAN-1 / NAL03-301
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Trevi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 26 Jun 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 Idiopathic Pulmonary Fibrosis (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 ER, Drug: PlaceboParticipants 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 | 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 52 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 2 months 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 | NAL ER 54 mg, Placebo |
Primary outcome
Relative Change from Baseline in 24-hour Cough Frequency at Week 26
Time frame: Baseline, Week 26
23 secondary outcomes
Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26
Time frame: Baseline, Week 26
Relative Change from Baseline in 24-hour Cough Frequency at Week 6
Time frame: Baseline, Week 6
Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26
Time frame: Baseline, Week 26
Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26
Time frame: Baseline, Week 26
Percentage of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS at Week 26
Time frame: Baseline, Week 26
Absolute Change from Baseline in the E:RS IPF Breathlessness Domain at Week 26
Time frame: Baseline, Week 26
Relative Change from Baseline in 24-hour Cough Frequency
Time frame: Baseline up to Week 54
Absolute Change from Baseline in 24-hour Cough Frequency
Time frame: Baseline up to Week 54
Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-Hour Cough Frequency
Time frame: Baseline up to Week 54
Absolute Change from Baseline in the E-RS:IPF Cough Domain
Time frame: Baseline up to Week 54
Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms)
Time frame: Baseline up to Week 54
Absolute Change from Baseline in the CS-NRS
Time frame: Baseline up to Week 54
Percentage of Participants Achieving a ≥3-Point Improvement from Baseline in CS-NRS
Time frame: Baseline up to Week 54
Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores
Time frame: Baseline up to Week 54
Percentage of Participants Achieving a 1.3-Point Increase (Improvement) from Baseline in LCQ Total Score
Time frame: Baseline up to Week 54
Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social)
Time frame: Baseline up to Week 54
Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 26
Time frame: Baseline, Week 26
Relative Change from Baseline in Awake Cough Frequency
Time frame: Baseline up to Week 54
Relative Change from Baseline in Sleep Cough Frequency
Time frame: Baseline up to Week 54
Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score
Time frame: Baseline up to Week 54
Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score
Time frame: Baseline up to Week 54
Percentage of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough
Time frame: Baseline up to Week 54
Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 57
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 13 Oct 2026.
- Click here to learn more about the participation in this trialLink provided by the sponsor.
- 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
22 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 22 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 13 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 22 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 26 (time frame: Baseline, Week 26). 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 13 Oct 2026.