Trial · NCT04030026
A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough
NCT04030026, Phase 2, Completed, Trevi Therapeutics; results first posted 2025-05-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough. Trials, record NCT04030026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04030026
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough
- NCT number
- NCT04030026
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Trevi Therapeutics
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- NAL ER, Placebo
- First posted
- 2019-07-23
- Last updated
- 2025-05-29
- Other registries' IDs
- eudract:2018-004744-31
- Results first posted
- 2025-05-29
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs) | Up to Day 72 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was defined as any AE that occurs after the first dose of study drug. TEAEs included both serious and non-serious TEAEs. |
| Primary | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Up to Day 72 | The clinical laboratory parameters included the urinalysis, hematology, serum chemistry, coagulation and liver function parameters. Clinical significance was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Changes in Vital Sign Parameters | Up to Day 72 | Vital signs measurements included blood pressure, heart rate, and respiration rate, body temperature, pulse oximetry, and weight. Clinical significance was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Changes in Physical Examination Parameters | Up to Day 72 | Physical examination included examination of the following body systems: general appearance, eyes, ears, nose, throat, head and neck, chest and lungs, cardiovascular, abdomen, musculoskeletal, lymphatic, dermatological, neurological, and extremities. Clinical significance was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) | Up to Day 72 | Changes in ECG data such as heart rate, rhythm, and other clinically significant abnormalities (left ventricular hypertrophy, pathological Q-waves) were measured. Clinical significance was determined by the investigator. |
| Primary | Change From Baseline in Forced Vital Capacity (FVC) at Day 21 | Baseline, Day 21 | Spirometry was used to assess FVC. It was used to assess pulmonary breathing mechanics. |
| Primary | Subjective Opiate Withdrawal (SOWS) Total Raw Score | Up to Day 72 | The SOWS is a self-administered scale for grading opioid withdrawal symptoms and was collected via the study issued e-diary. It consisted of 16 symptoms related to how the participant felt. Each symptom was scored between 0 to 4. The total score ranges between 0 to 64, higher score indicates more severe symptoms. |
| Primary | Daytime Cough Frequency at Baseline | At Baseline | Daytime cough was defined as cough that occurs between the time that the participant is a wake in the 24 hours after the digital cough monitor was applied for use. Assessment was done using objective digital cough monitoring. Baseline was defined as the last available assessment prior to the first Treatment Period 1 IP intake. |
| Primary | Percent Change From Baseline in Daytime Cough Frequency at Day 22 | Baseline, Day 22 | Daytime cough was defined as cough that occurs between the time that the participant is a wake in the 24 hours after the digital cough monitor was applied for use. Assessment was done using objective digital cough monitoring. Percent change in daytime cough frequency (coughs per hour) from baseline was assessed. Baseline was defined as the last available assessment prior to the first Treatment Period 1 IP intake. |
| Secondary | Change From Baseline in Daytime Cough Frequency at Day 22 | Baseline, Day 22 | Daytime cough was defined as cough that occurs between the time that the participant wakes up and the time that the participant goes to bed. Assessment was done using objective digital cough monitoring. The change in daytime cough frequency (coughs per hour) from baseline was assessed. Baseline was defined as the last available assessment prior to the first Treatment Period 1 IP intake. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs) | Up to Day 72 | SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Up to Day 72 | SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Vital Sign Parameters | Up to Day 72 | SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Physical Examination Parameters | Up to Day 72 | SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) | Up to Day 72 | SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Forced Vital Capacity (FVC) at Day 21 | Baseline, Day 21 | Participants in SAS were analyzed.3 participants did not receive at least 1 dose of NAL ER but received placebo and 1 participant did not receive at least 1 dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).Overall number of participants analyzed'=participants who were evaluable for the OM. | litre(s) | MEAN |
| PRIMARY | Subjective Opiate Withdrawal (SOWS) Total Raw Score | Up to Day 72 | Participants in SAS were analyzed.3 participants did not receive at least 1 dose of NAL ER but received placebo and 1 participant did not receive at least 1 dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).Overall number of participants analyzed'=participants who were evaluable for the OM. | score on a scale | MEAN |
| PRIMARY | Daytime Cough Frequency at Baseline | At Baseline | Full Analysis Set (FAS) included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. | coughs per hour | MEAN |
| PRIMARY | Percent Change From Baseline in Daytime Cough Frequency at Day 22 | Baseline, Day 22 | FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Overall number of participants analyzed' included those participants who were evaluable for this outcome measure. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Daytime Cough Frequency at Day 22 | Baseline, Day 22 | FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Overall number of participants analyzed' included those participants who were evaluable for this outcome measure. | coughs per hour | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs) | NAL ER | 35 | Participants | ||
| Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs) | Placebo | 26 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | NAL ER | Urinalysis | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Placebo | Urinalysis | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | NAL ER | Hematology | 1 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Placebo | Hematology | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | NAL ER | Serum Chemistry | 1 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Placebo | Serum Chemistry | 1 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | NAL ER | Coagulation | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Placebo | Coagulation | 1 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (22 Days) | STARTED | First NAL ER Then Placebo | 21 | |
| Treatment Period 1 (22 Days) | STARTED | First Placebo Then NAL ER | 21 | |
| Treatment Period 1 (22 Days) | Safety Analysis Set | First NAL ER Then Placebo | 20 | |
| Treatment Period 1 (22 Days) | Safety Analysis Set | First Placebo Then NAL ER | 21 | |
| Treatment Period 1 (22 Days) | COMPLETED | First NAL ER Then Placebo | 19 | |
| Treatment Period 1 (22 Days) | COMPLETED | First Placebo Then NAL ER | 19 | |
| Treatment Period 1 (22 Days) | NOT COMPLETED | First NAL ER Then Placebo | 2 | |
| Treatment Period 1 (22 Days) | NOT COMPLETED | First Placebo Then NAL ER | 2 | |
| Treatment Period 2 (22 Days) | STARTED | First NAL ER Then Placebo | 19 | |
| Treatment Period 2 (22 Days) | STARTED | First Placebo Then NAL ER | 19 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | NAL ER | 10 | 38 | |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 40 | |
| other | Somnolence | Nervous system disorders | NAL ER | 9 | 38 | |
| other | Somnolence | Nervous system disorders | Placebo | 1 | 40 | |
| other | Headache | Nervous system disorders | NAL ER | 5 | 38 | |
| other | Headache | Nervous system disorders | Placebo | 5 | 40 | |
| other | Lethargy | Nervous system disorders | NAL ER | 3 | 38 | |
| other | Lethargy | Nervous system disorders | Placebo | 2 | 40 | |
| other | Fatigue | General disorders | NAL ER | 12 | 38 | |
| other | Fatigue | General disorders | Placebo | 3 | 40 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NAL ER | 0 | 42 |
| Total, all-cause mortality | Placebo | 0 | 42 |
| Total, other adverse events | NAL ER | 35 | 38 |
| Total, other adverse events | Placebo | 26 | 40 |
| Total, serious adverse events | NAL ER | 1 | 38 |
| Total, serious adverse events | Placebo | 1 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38320144 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NAL ER vs Placebo: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) | Trial comparisons |
| NAL ER vs Placebo: Number of Participants With Clinically Significant Changes in Physical Examination Parameters | Trial comparisons |
| NAL ER vs Placebo: Number of Participants With Clinically Significant Changes in Vital Sign Parameters | Trial comparisons |
| NAL ER vs Placebo: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| NAL ER vs Placebo: deaths from any cause | Trial comparisons |
| NAL ER vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04030026
GET https://conductscience.org/api/trials/v1/NCT04030026/results?page=2