Clinical trial NCT04030026: A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis (IPF) With Nalbuphine ER Tablets for the Treatment of Cough
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Nalbuphine
Cough
Idiopathic Pulmonary Fibrosis
Pharmacokinetics
Lead sponsor: Trevi Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2019-07-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blinded, placebo-controlled, 2-Treatment, 2-Period Crossover Study
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of nalbuphine ER tablets in the study population and to evaluate the effect of NAL ER tablets on the mean daytime cough frequency (coughs per hour) at Day 22 (dose 162 mg BID) as compared to placebo tablets.


Eligibility criteria: Inclusion Criteria:

1. Individuals diagnosed with Idiopathic Pulmonary Fibrosis
2. Chronic cough \> 8 weeks.
3. Daytime cough severity score ≥ 4 on Cough Severity Numerical Rating Scale at screening.

Exclusion Criteria:

1. The following conditions are excluded:

   1. Interstitial lung disease (ILD) known to be caused by domestic and occupational environmental exposures.
   2. Interstitial lung disease (ILD) known to be caused by connective tissue disease.
   3. Interstitial lung disease (ILD) known to be caused by drug related toxicity.

      2. Currently on continuous oxygen therapy.

      3. History of substance abuse that, as determined by the Investigator, may interfere with the conduct of the study.

Primary outcomes:
measure: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 72
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
timeFrame: Up to Day 72
measure: Number of Participants With Clinically Significant Changes in Vital Sign Parameters
timeFrame: Up to Day 72
measure: Number of Participants With Clinically Significant Changes in Physical Examination Parameters
timeFrame: Up to Day 72
measure: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)
timeFrame: Up to Day 72
measure: Change From Baseline in Forced Vital Capacity (FVC) at Day 21
timeFrame: Baseline, Day 21
measure: Subjective Opiate Withdrawal (SOWS) Total Raw Score
timeFrame: Up to Day 72
measure: Daytime Cough Frequency at Baseline
timeFrame: At Baseline
measure: Percent Change From Baseline in Daytime Cough Frequency at Day 22
timeFrame: Baseline, Day 22
Secondary outcomes:
measure: Change From Baseline in Daytime Cough Frequency at Day 22
timeFrame: Baseline, Day 22
measure: Percent Change From Baseline in 24-Hour Cough Frequency at Day 22
timeFrame: Baseline, Day 22
measure: Percent Change From Baseline in Nighttime Cough Frequency at Day 22
timeFrame: Baseline, Day 22
measure: Mean Change From Baseline in the Evaluating Respiratory Symptoms (E-RS) Diary Cough Subscale at Days 9, 16, and 22
timeFrame: Baseline, Days 9, 16, and 22
measure: Mean Change From Baseline in E-RS Breathlessness Score at Days 9, 16, and 22
timeFrame: Baseline, Days 9, 16, and 22
measure: Mean Change From Baseline in the Cough Severity Numerical Rating Scale (NRS) at Days 8, 15, and 21
timeFrame: Baseline, Days 8, 15, and 21
measure: Mean Change From Baseline in the 14-item EXAcerbation of Chronic Pulmonary Disease Tool (EXACT) v1.1 e-Diary Tool Total Score at Days 9, 16, and 22
timeFrame: Baseline, Days 9, 16, and 22
measure: Mean Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 Fatigue Short Form 7a Scale Total Score at Day 21
timeFrame: Baseline, Day 21
measure: Clinical Global Impression of Change (CGI-C) Over Time Measured at Day 21
timeFrame: At Day 21
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: 09
city: Cottingham
country: United Kingdom
facility: 08
city: Dundee
country: United Kingdom
facility: 17
city: Edinburgh
country: United Kingdom
facility: 13
city: London
country: United Kingdom
facility: 04
city: London
country: United Kingdom
facility: 01
city: Manchester
country: United Kingdom
facility: 02
city: Newcastle Upon Tyne
country: United Kingdom
facility: 10
city: Nottingham
country: United Kingdom
facility: 06
city: Oxford
country: United Kingdom
facility: 14
city: Southampton
country: United Kingdom
facility: 03
Study officials:
affiliation: Trevi Therapeutics, Inc
name: Thomas Sciascia
role: STUDY_DIRECTOR
References: