Status:
COMPLETED
A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough
Lead Sponsor:
Trevi Therapeutics
Collaborating Sponsors:
Parexel
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 (d...
Eligibility Criteria
Inclusion
- Individuals diagnosed with Idiopathic Pulmonary Fibrosis
- Chronic cough \> 8 weeks.
- Daytime cough severity score ≥ 4 on Cough Severity Numerical Rating Scale at screening.
Exclusion
- The following conditions are excluded:
- Interstitial lung disease (ILD) known to be caused by domestic and occupational environmental exposures.
- Interstitial lung disease (ILD) known to be caused by connective tissue disease.
- 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.
Key Trial Info
Start Date :
October 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04030026
Start Date
October 29 2019
End Date
May 27 2022
Last Update
May 29 2025
Active Locations (11)
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1
09
Cambridge, United Kingdom, CB23 3RE
2
08
Cottingham, United Kingdom, HU16 5JQ
3
17
Dundee, United Kingdom, DD1 9SY
4
13
Edinburgh, United Kingdom