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Cough Reduction in IPF With Nalbuphine ER

Study Purpose

This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study of nalbuphine ER (NAL ER). After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms.

  • - Arm 1: Placebo.
  • - Arm 2: 27 mg nalbuphine ER.
  • - Arm 3: 54 mg nalbuphine ER.
  • - Arm 4: 108 mg nalbuphine ER.
Each arm will be titrated to their fixed dose during the blinded 2-week Titration period followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug.

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 and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of IPF as determined by the Principal Investigator based on ATS/ERS/JRS/ALAT guidelines.
  • - Cough Severity Score ≥ 4 on CS-NRS (Cough Severity Numerical Rating Scale) during the Screening period and Baseline.
  • - History of chronic cough for at least 8 weeks before screening.
  • - SpO2 ≥ 92%, taken after at least 5 minutes in a sitting position, undisturbed and non-stimulated (Saturation of Hemoglobin with Oxygen as Measured by Pulse Oximetry).
  • - FVC ≥ 40% predicted of normal - Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines.
  • - DLCO ≥ 25% predicted of normal - Diffusing capacity of the lung for carbon monoxide corrected for hemoglobin, assessed within the last 12 weeks, or at the time of screening.

Exclusion Criteria:

  • - Currently on continuous oxygen therapy for longer than 16 hours at any level or delivered by any modality.
Intermittent oxygen use of any duration over any given 24-hour period is allowed.
  • - Inadequate swallow reflex as assessed by the ability to sip 3 fluid oz (or 89 mL) of water without coughing or choking.
  • - Upper or lower respiratory tract infection in the last 8 weeks prior to the baseline visit.
  • - Clinical history of aspiration pneumonitis.
  • - Diagnosis of sleep apnea.
  • - Abnormal kidney or liver functions based on Screening lab results.
  • - Known hypersensitivity to nalbuphine or to NAL ER excipients.
  • - History of major psychiatric disorder.
  • - History of substance abuse.
  • - Significant medical condition or other factors that may interfere with the subject's ability to successfully complete the study.
  • - Pregnant or lactating female subject.
  • - Known intolerance (gastrointestinal, central nervous system symptoms), hypersensitivity, drug allergy following the use of an opioid drug.
  • - Use of opiates is prohibited within 14 days prior to the baseline visit.
  • - Use of benzodiazepines are prohibited within 14 days prior to the baseline visit and for the duration of the study.
  • - Monoamine oxidase inhibitors (MAOIs) including methylene blue (methylthioninium chloride) and the antibiotic linezolid are prohibited within 14 days prior to the baseline visit and for the duration of the study.
  • - Use of oral corticosteroid cough treatment is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.
  • - Exposure to any investigational medication, including placebo, is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.
  • - Medications prescribed as cough suppressants are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study.
  • - Use of medications that affect serotonergic neurotransmission and that when used concomitantly with opioids can increase the risk of serotonin syndrome are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study.
  • - Anti-fibrotic medications are prohibited unless on a stable dose for 8 weeks prior to the baseline visit and are expected to remain on that dose for the duration of the study.
  • - Strong inhibitors/inducers of the P450 Isozymes are prohibited unless on a stable dose for 14-days prior to baseline visit and are expected to remain on that dose for the duration of the study.
  • - Use of a medication having a "known risk" of Torsade de Pointes (categorized as "KR" on the Credible Meds® website.
) 4 weeks prior to Baseline.
  • - Use of unstable doses of medications associated with a potential risk of QT prolongation but not clearly associated with Torsade de Pointes within 4 weeks of screening.

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.

NCT05964335
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.

David Clark, MD
Principal Investigator Affiliation Trevi Therapeutics
Agency Class

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

Industry
Overall Status Recruiting
Countries Australia, Canada, Chile, Germany, Italy, Netherlands, Poland, Spain, Turkey, United Kingdom
Conditions

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

Idiopathic Pulmonary Fibrosis
Additional Details

This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study. After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms.

  • - Arm 1: Placebo.
  • - Arm 2: 27 mg nalbuphine ER.
  • - Arm 3: 54 mg nalbuphine ER.
  • - Arm 4: 108 mg nalbuphine ER.
Each arm will be titrated to their fixed dose during the blinded 2-week Titration period according to Table: Dosing Scheme, followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug. Subjects will be taken off study drug at the end of the Fixed Dose Period and followed off treatment for an additional 2 weeks.

Arms & Interventions

Arms

Experimental: NAL ER 27 mg

BID

Experimental: NAL ER 54 mg

BID

Experimental: NAL ER 108 mg

BID

Placebo Comparator: Placebo

Placebo, tablets BID

Interventions

Drug: - nalbuphine ER 27 mg

Oral tablets

Drug: - Placebo

Oral tablets

Drug: - nalbuphine ER 54 mg

Oral Tablets

Drug: - nalbuphine ER 108 mg

Oral tablets

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

Eastern Health-Box Hill Hospital, Box Hill, Australia

Status

Not yet recruiting

Address

Eastern Health-Box Hill Hospital

Box Hill, , 3128

Concord Repatriation General Hospital, Concord, Australia

Status

Recruiting

Address

Concord Repatriation General Hospital

Concord, , 2139

Austin Hospital, Heidelberg, Australia

Status

Not yet recruiting

Address

Austin Hospital

Heidelberg, , 3084

Respiratory Clinical Trials Pty Ltd, Kent Town, Australia

Status

Recruiting

Address

Respiratory Clinical Trials Pty Ltd

Kent Town, , 5067

Site Contact

B Gleaves

bhgleaves@rctc.com.au

203-654-3284

TrialsWest Pty Ltd, Spearwood, Australia

Status

Recruiting

Address

TrialsWest Pty Ltd

Spearwood, , 6163

Site Contact

M Davies

admin@trialswest.com.au

203-654-3284

Westmead Hospital, Westmead, Australia

Status

Recruiting

Address

Westmead Hospital

Westmead, , 2145

Dynamic Drug Advancement, Ajax, Canada

Status

Recruiting

Address

Dynamic Drug Advancement

Ajax, , L1S 2J5

Centre for Lung Health Clinic, Vancouver, Canada

Status

Recruiting

Address

Centre for Lung Health Clinic

Vancouver, , V5Z 1M9

Site Contact

M Santos

marion.santos@vch.ca

203-654-3284

Vancouver, Canada

Status

Not yet recruiting

Address

The Pacific Lung Health Centre - St. Pauls Hospital

Vancouver, , V6Z 1Y6

Hospital Regional de Concepcion, Concepcion, Chile

Status

Not yet recruiting

Address

Hospital Regional de Concepcion

Concepcion, , 4040324

Quillota, Chile

Status

Not yet recruiting

Address

Centro de Investigaciones Medicas Cemedin Ltda.

Quillota, , 2260877

Clinica Universidad de los Andes, Santiago, Chile

Status

Not yet recruiting

Address

Clinica Universidad de los Andes

Santiago, , 7620157

Centro de Investigacion del Maule, Talca, Chile

Status

Not yet recruiting

Address

Centro de Investigacion del Maule

Talca, , 346507

Hospital Carlos Van Buren, Valparaiso, Chile

Status

Not yet recruiting

Address

Hospital Carlos Van Buren

Valparaiso, , 2352499

Oncocentro APYS, Vina del Mar, Chile

Status

Not yet recruiting

Address

Oncocentro APYS

Vina del Mar, , 2520598

Essen, Germany

Status

Recruiting

Address

Universitatsklinik Ruhrlandklinik, Westdeutsches Lungenzentrum

Essen, , 45239

Frankfurt am Main, Germany

Status

Recruiting

Address

IKF Institut fuer klinische Forschung Frankfurt

Frankfurt am Main, , 60596

Site Contact

B Buelow-Johansen

buelow-johansen@ikf-pneumologie.de

+4969695972580

Hannover, Germany

Status

Not yet recruiting

Address

Medizinische Hochschule Hannover, Hannover Medical School

Hannover, , 30625

University Hospital of Leipzig, Leipzig, Germany

Status

Not yet recruiting

Address

University Hospital of Leipzig

Leipzig, , 04103

Mainz, Germany

Status

Recruiting

Address

IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz

Mainz, , 55128

Krankenhaus Bethanien, Solingen, Germany

Status

Recruiting

Address

Krankenhaus Bethanien

Solingen, , 42699

Bologna, Italy

Status

Not yet recruiting

Address

AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna

Bologna, , 40138

Catania, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele- Ospedale Gaspare Rodolico

Catania, , 95123

Foggia, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliero Universitaria Ospedali Riuniti Di Foggia

Foggia, , 71122

Ospedale San Giuseppe Multimedica SpA, Milano, Italy

Status

Not yet recruiting

Address

Ospedale San Giuseppe Multimedica SpA

Milano, , 20123

Azienda Ospedaliera San Gerardo di Monza, Monza, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera San Gerardo di Monza

Monza, , 20900

Napoli, Italy

Status

Not yet recruiting

Address

Azienda ospedaliera dei colli /Universita degli Studi di Napoli Federico II

Napoli, , 80131

Azienda Ospedaliera di Padova, Padua, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera di Padova

Padua, , 35100

Palermo, Italy

Status

Not yet recruiting

Address

Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione (Ismett) Di Palermo

Palermo, , 90127

Roma, Italy

Status

Not yet recruiting

Address

Università Degli Studi Tor Vergata - Roma - Prof. Vespasiani

Roma, , 00133

Rome, Italy

Status

Not yet recruiting

Address

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , 00168

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands

Status

Not yet recruiting

Address

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , 5223 GZ

HMC (Haaglanden Medisch Centrum) Bronovo, Den Haag, Netherlands

Status

Recruiting

Address

HMC (Haaglanden Medisch Centrum) Bronovo

Den Haag, , 2597 AX

Site Contact

M Overbeek

m.overbeek@haaglandenmc.nl

+31 88 9797900

Martini Ziekenhuis, Groningen, Netherlands

Status

Recruiting

Address

Martini Ziekenhuis

Groningen, , 9728 NT

Site Contact

H Kramer

henk.kramer@mzh.nl

+31 505245930

Erasmus Medisch Centrum 1, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus Medisch Centrum 1

Rotterdam, , 3015 GD

Site Contact

M Wijsenbeek-Lourens

m.wijsenbeek-lourens@erasmusmc.nl

+31 107030033

Uniwersyteckie Centrum Kliniczne (UCK), Gdansk, Poland

Status

Not yet recruiting

Address

Uniwersyteckie Centrum Kliniczne (UCK)

Gdansk, , 80-952

Krakow, Poland

Status

Recruiting

Address

Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o., sp.k.

Krakow, , 31-637

Lodz, Poland

Status

Not yet recruiting

Address

Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

Lodz, , 90-153

Olsztyn, Poland

Status

Recruiting

Address

Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie

Olsztyn, , 10-357

Site Contact

A Doboszynska

anna.doboszynska@wp.pl

+48 895322985

Sosnowiec, Poland

Status

Not yet recruiting

Address

Pulmag Grzegorz Gasior Marzena Kociolek Sp. Cywilna

Sosnowiec, , 41-208

Szczecin, Poland

Status

Not yet recruiting

Address

Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie

Szczecin, , 70-891

Clinica Mi Tres Torres Barcelona, Barcelona, Spain

Status

Recruiting

Address

Clinica Mi Tres Torres Barcelona

Barcelona, , 08017

Site Contact

J Roldan Sanchez

juan.roldan@giromedinstitute.com

+34 627942876

Hospital Universitari de Bellvitge, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari de Bellvitge

Barcelona, , 08907

Site Contact

M Molina-Molina

ufip@bellvitgehospital.cat

+34 665222569

Hospital La Milagrosa, Madrid, Spain

Status

Recruiting

Address

Hospital La Milagrosa

Madrid, , 28010

Site Contact

W Giron Matute

walter_giron2@hotmail.com

+34658566028

HUMV, Santander, Spain

Status

Recruiting

Address

HUMV

Santander, , 39008

Site Contact

J.M. Cifrian Martínez

josemanuel.cifrian@scsalud.es

+34 942203565

Ankara, Turkey

Status

Recruiting

Address

Gulhane Askeri Tip Akademisi (GATA) - Gulhane Askeri Tip Fakultesi (Gulhane Military Medical Academy and Medical School)

Ankara, , 06010

Akdeniz University Faculty of Medicine, Antalya, Turkey

Status

Recruiting

Address

Akdeniz University Faculty of Medicine

Antalya, , 07058

Canakkale, Turkey

Status

Not yet recruiting

Address

Canakkale Onsekiz Mart Universitesi (COMU) - Tip Fakultesi Hastanesi

Canakkale, , 17100

Istanbul, Turkey

Status

Recruiting

Address

Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi

Istanbul, , 34844

Ege University Medical Faculty, Izmir, Turkey

Status

Not yet recruiting

Address

Ege University Medical Faculty

Izmir, , 35040

Kocaeli University Medical Faculty, Izmit, Turkey

Status

Not yet recruiting

Address

Kocaeli University Medical Faculty

Izmit, , 41380

Selcuk Universty Medical Faculty, Selcuklu, Turkey

Status

Not yet recruiting

Address

Selcuk Universty Medical Faculty

Selcuklu, , 42131

Royal Papworth Hospital, Cambridge, United Kingdom

Status

Not yet recruiting

Address

Royal Papworth Hospital

Cambridge, , CB2 0AY

Cottingham, United Kingdom

Status

Recruiting

Address

Hull and East Yorkshire - Castle Hill Hospital

Cottingham, , HU16 5JQ

Site Contact

C Wright

c.wright@hull.ac.uk

+44 1482 461800

Royal Infirmary Of Edinburgh, Edinburgh, United Kingdom

Status

Recruiting

Address

Royal Infirmary Of Edinburgh

Edinburgh, , EH16 4SA

Altnagelvin Area Hospital, Londonderry, United Kingdom

Status

Recruiting

Address

Altnagelvin Area Hospital

Londonderry, , BT47 6SB

University College London, London, United Kingdom

Status

Recruiting

Address

University College London

London, , NW1 2BU

Site Contact

D Basire

d.basire@ucl.ac.uk

203-654-3284

Royal Brompton Hospital, London, United Kingdom

Status

Recruiting

Address

Royal Brompton Hospital

London, , SW3 6NP

Site Contact

M Villamor

m.villamor@rbht.nhs.uk

203-654-3284

Wythenshawe Hospital, Manchester, United Kingdom

Status

Recruiting

Address

Wythenshawe Hospital

Manchester, , M23 9LT

Norfolk and Norwich University Hospital, Norwich, United Kingdom

Status

Recruiting

Address

Norfolk and Norwich University Hospital

Norwich, , NR4 7UY

Site Contact

L Hudig

LISA.HUDIG@nnuh.nhs.uk

203-654-3284

Nottingham City Hospital, Nottingham, United Kingdom

Status

Not yet recruiting

Address

Nottingham City Hospital

Nottingham, , NG5 1PB

Churchill Hospital, Oxford, United Kingdom

Status

Not yet recruiting

Address

Churchill Hospital

Oxford, , OX3 7LE

Southampton General Hospital, Southampton, United Kingdom

Status

Recruiting

Address

Southampton General Hospital

Southampton, , SO16 6YD

Site Contact

J Richards

jennifer.richards@uhs.nhs.uk

203-654-3284