A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough
NCT ID: NCT04030026
Last Updated: 2025-05-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2019-10-29
2022-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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NAL ER then placebo
Participants received NAL ER in treatment period 1 at dose 27 mg once daily (QD) to 54 mg twice daily (BID) over a 5-day period and then maintained at 54 mg BID for 4 days. Dose was increased to 108 mg BID for 1 week then to 162 mg BID for 6 days, followed by placebo matching NAL ER for 3 weeks in treatment period 2. Both the treatment periods were separated by 2 weeks of washout period.
NAL ER
Participants received NAL ER 27 mg QD, 27 mg BID, 54 mg BID, 108 mg BID, 162 mg BID.
Placebo
Participants received Placebo tablet (matching NAL ER ).
Placebo then NAL ER
Participants received placebo matching NAL ER for 3 weeks in treatment period 1 followed by NAL ER in treatment period 2 at dose 27 mg QD to 54 mg BID over a 5-day period and then maintained at 54 mg BID for 4 days. Dose was increased to 108 mg BID for 1 week then to 162 mg BID for 6 days. Both the treatment periods were separated by 2 weeks of washout period.
NAL ER
Participants received NAL ER 27 mg QD, 27 mg BID, 54 mg BID, 108 mg BID, 162 mg BID.
Placebo
Participants received Placebo tablet (matching NAL ER ).
Interventions
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NAL ER
Participants received NAL ER 27 mg QD, 27 mg BID, 54 mg BID, 108 mg BID, 162 mg BID.
Placebo
Participants received Placebo tablet (matching NAL ER ).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic cough \> 8 weeks.
3. Daytime cough severity score ≥ 4 on Cough Severity Numerical Rating Scale at screening.
Exclusion Criteria
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.
18 Years
80 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Trevi Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Sciascia
Role: STUDY_DIRECTOR
Trevi Therapeutics, Inc
Locations
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09
Cambridge, , United Kingdom
08
Cottingham, , United Kingdom
17
Dundee, , United Kingdom
13
Edinburgh, , United Kingdom
04
London, , United Kingdom
01
London, , United Kingdom
02
Manchester, , United Kingdom
10
Newcastle upon Tyne, , United Kingdom
06
Nottingham, , United Kingdom
14
Oxford, , United Kingdom
03
Southampton, , United Kingdom
Countries
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References
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Maher TM, Avram C, Bortey E, Hart SP, Hirani N, Molyneux PL, Porter JC, Smith JA, Sciascia T. Nalbuphine Tablets for Cough in Patients with Idiopathic Pulmonary Fibrosis. NEJM Evid. 2023 Aug;2(8):EVIDoa2300083. doi: 10.1056/EVIDoa2300083. Epub 2023 May 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004744-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TR12
Identifier Type: -
Identifier Source: org_study_id
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