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.
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 |
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.
- - 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.
- - 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 |
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.
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
Status
Not yet recruiting
Address
Eastern Health-Box Hill Hospital
Box Hill, , 3128
Status
Recruiting
Address
Concord Repatriation General Hospital
Concord, , 2139
Status
Not yet recruiting
Address
Austin Hospital
Heidelberg, , 3084
Status
Recruiting
Address
Respiratory Clinical Trials Pty Ltd
Kent Town, , 5067
Status
Recruiting
Address
TrialsWest Pty Ltd
Spearwood, , 6163
Status
Recruiting
Address
Westmead Hospital
Westmead, , 2145
Status
Recruiting
Address
Dynamic Drug Advancement
Ajax, , L1S 2J5
Status
Recruiting
Address
Centre for Lung Health Clinic
Vancouver, , V5Z 1M9
Status
Not yet recruiting
Address
The Pacific Lung Health Centre - St. Pauls Hospital
Vancouver, , V6Z 1Y6
Status
Not yet recruiting
Address
Hospital Regional de Concepcion
Concepcion, , 4040324
Status
Not yet recruiting
Address
Centro de Investigaciones Medicas Cemedin Ltda.
Quillota, , 2260877
Status
Not yet recruiting
Address
Clinica Universidad de los Andes
Santiago, , 7620157
Status
Not yet recruiting
Address
Centro de Investigacion del Maule
Talca, , 346507
Status
Not yet recruiting
Address
Hospital Carlos Van Buren
Valparaiso, , 2352499
Status
Not yet recruiting
Address
Oncocentro APYS
Vina del Mar, , 2520598
Status
Recruiting
Address
Universitatsklinik Ruhrlandklinik, Westdeutsches Lungenzentrum
Essen, , 45239
Status
Recruiting
Address
IKF Institut fuer klinische Forschung Frankfurt
Frankfurt am Main, , 60596
Status
Not yet recruiting
Address
Medizinische Hochschule Hannover, Hannover Medical School
Hannover, , 30625
Status
Not yet recruiting
Address
University Hospital of Leipzig
Leipzig, , 04103
Status
Recruiting
Address
IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz
Mainz, , 55128
Status
Recruiting
Address
Krankenhaus Bethanien
Solingen, , 42699
Status
Not yet recruiting
Address
AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna
Bologna, , 40138
Status
Not yet recruiting
Address
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele- Ospedale Gaspare Rodolico
Catania, , 95123
Status
Not yet recruiting
Address
Azienda Ospedaliero Universitaria Ospedali Riuniti Di Foggia
Foggia, , 71122
Status
Not yet recruiting
Address
Ospedale San Giuseppe Multimedica SpA
Milano, , 20123
Status
Not yet recruiting
Address
Azienda Ospedaliera San Gerardo di Monza
Monza, , 20900
Status
Not yet recruiting
Address
Azienda ospedaliera dei colli /Universita degli Studi di Napoli Federico II
Napoli, , 80131
Status
Not yet recruiting
Address
Azienda Ospedaliera di Padova
Padua, , 35100
Status
Not yet recruiting
Address
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione (Ismett) Di Palermo
Palermo, , 90127
Status
Not yet recruiting
Address
Università Degli Studi Tor Vergata - Roma - Prof. Vespasiani
Roma, , 00133
Status
Not yet recruiting
Address
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, , 00168
Status
Not yet recruiting
Address
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , 5223 GZ
Status
Recruiting
Address
HMC (Haaglanden Medisch Centrum) Bronovo
Den Haag, , 2597 AX
Status
Recruiting
Address
Martini Ziekenhuis
Groningen, , 9728 NT
Status
Recruiting
Address
Erasmus Medisch Centrum 1
Rotterdam, , 3015 GD
Status
Not yet recruiting
Address
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, , 80-952
Status
Recruiting
Address
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o., sp.k.
Krakow, , 31-637
Status
Not yet recruiting
Address
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
Lodz, , 90-153
Status
Recruiting
Address
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, , 10-357
Status
Not yet recruiting
Address
Pulmag Grzegorz Gasior Marzena Kociolek Sp. Cywilna
Sosnowiec, , 41-208
Status
Not yet recruiting
Address
Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie
Szczecin, , 70-891
Status
Recruiting
Address
Clinica Mi Tres Torres Barcelona
Barcelona, , 08017
Status
Recruiting
Address
Hospital Universitari de Bellvitge
Barcelona, , 08907
Status
Recruiting
Address
Hospital La Milagrosa
Madrid, , 28010
Status
Recruiting
Address
HUMV
Santander, , 39008
Status
Recruiting
Address
Gulhane Askeri Tip Akademisi (GATA) - Gulhane Askeri Tip Fakultesi (Gulhane Military Medical Academy and Medical School)
Ankara, , 06010
Status
Recruiting
Address
Akdeniz University Faculty of Medicine
Antalya, , 07058
Status
Not yet recruiting
Address
Canakkale Onsekiz Mart Universitesi (COMU) - Tip Fakultesi Hastanesi
Canakkale, , 17100
Status
Recruiting
Address
Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
Istanbul, , 34844
Status
Not yet recruiting
Address
Ege University Medical Faculty
Izmir, , 35040
Status
Not yet recruiting
Address
Kocaeli University Medical Faculty
Izmit, , 41380
Status
Not yet recruiting
Address
Selcuk Universty Medical Faculty
Selcuklu, , 42131
Status
Not yet recruiting
Address
Royal Papworth Hospital
Cambridge, , CB2 0AY
Status
Recruiting
Address
Hull and East Yorkshire - Castle Hill Hospital
Cottingham, , HU16 5JQ
Status
Recruiting
Address
Royal Infirmary Of Edinburgh
Edinburgh, , EH16 4SA
Status
Recruiting
Address
Altnagelvin Area Hospital
Londonderry, , BT47 6SB
Status
Recruiting
Address
University College London
London, , NW1 2BU
Status
Recruiting
Address
Royal Brompton Hospital
London, , SW3 6NP
Status
Recruiting
Address
Wythenshawe Hospital
Manchester, , M23 9LT
Status
Recruiting
Address
Norfolk and Norwich University Hospital
Norwich, , NR4 7UY
Status
Not yet recruiting
Address
Nottingham City Hospital
Nottingham, , NG5 1PB
Status
Not yet recruiting
Address
Churchill Hospital
Oxford, , OX3 7LE
Status
Recruiting
Address
Southampton General Hospital
Southampton, , SO16 6YD