A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough

Study Purpose

To investigate the efficacy and safety of Nalbuphine ER (NAL ER) tablets in subjects diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and evaluate it's treatment of cough in these patients. This is a two-treatment, 2-period crossover study. Subjects will be randomized in Treatment Period 1 to either NAL ER or matching placebo and evaluate for approximately 21 days. After completion of the first phase, subjects who received NAL ER will crossover to placebo and subjects who received placebo will crossover to NAL ER to complete Treatment Period 2.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04030026
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Trevi Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Thomas Sciascia
Principal Investigator Affiliation Trevi Therapeutics, Inc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Not yet recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Nalbuphine, Idiopathic Pulmonary Fibrosis, Cough
Additional Details

This is a double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover efficacy and safety study in IPF subjects with NAL ER tablets for the treatment of cough. The study consists of 2 treatment periods of 3 weeks, each followed by a washout period of 2 weeks. Treatment Period 1: During Treatment Period 1, eligible subjects will be randomized (1:1) to one of the following treatment arms:

  • - Arm 1: Active NAL ER followed by crossover Placebo in Treatment Period 2 - Arm 2: Placebo followed by crossover NAL ER in Treatment Period 2 Following 3 weeks of dosing in Treatment Period 1, subjects will complete a 2-week washout period before entering Treatment Period 2.
Subjects assigned to Arm 1 will receive placebo and subjects assigned to Arm 2 will receive NAL ER during Treatment Period 2. A final 2-week washout period will occur at the completion of Treatment Period 2. NAL ER Dosing Subjects on NAL ER will have the dose titrated from 27 mg once daily (QD) to 54 mg BID over a 5-day period and then maintained at 54 mg BID for approximately 4 days. Doses will be subsequently escalated and maintained at 108 mg BID over 1 week and then to 162 mg BID over 6 days.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

03, Southampton, United Kingdom

Status

Not yet recruiting

Address

03

Southampton, , SO16 6YD

06, Nottingham, United Kingdom

Status

Not yet recruiting

Address

06

Nottingham, , NG5 1PB

07, Norwich, United Kingdom

Status

Not yet recruiting

Address

07

Norwich, , NR4 7UY

10, Newcastle Upon Tyne, United Kingdom

Status

Not yet recruiting

Address

10

Newcastle Upon Tyne, , NE1 4LP

02, Manchester, United Kingdom

Status

Not yet recruiting

Address

02

Manchester, , M23 9LT

01, London, United Kingdom

Status

Not yet recruiting

Address

01

London, , SW3 6NP

04, London, United Kingdom

Status

Not yet recruiting

Address

04

London, , NW1 2BU

05, Liverpool, United Kingdom

Status

Not yet recruiting

Address

05

Liverpool, , L9 7AL

08, Cottingham, United Kingdom

Status

Not yet recruiting

Address

08

Cottingham, , HU16 5JQ

09, Cambridge, United Kingdom

Status

Not yet recruiting

Address

09

Cambridge, , CB23 3RE

11, Belfast, United Kingdom

Status

Not yet recruiting

Address

11

Belfast, , BT9 7AB

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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