A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Participants With Refractory Chronic Cough
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of Nalbuphine ER Extended-release tablets for the treatment of participants with RCC.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Meets society guideline-based criteria for a diagnosis of RCC defined as:
‣ Insufficient improvement in cough after treatment for any identified cough-associated conditions.
⁃ Unexplained cough for which an underlying condition has not been determined despite adequate investigation with diagnostic tests and trials of therapy.
• Persistent and chronic cough for at least one year prior to Screening.
• Chest computed tomography (CT) or chest radiograph of the thorax performed within the last 24 months and after the onset of chronic cough OR the procedure completed by the Investigator during the Screening period, that does not show any abnormality considered to be significantly contributing to the RCC in the opinion of the Principal Investigator.
• 24-hour objective cough frequency ≥10 coughs/hour based on VitaloJAK® cough monitor recording performed during the Screening and Placebo Run-in Periods as well as a minimum recording duration of 20 hours suitable for analysis during the placebo Run-in assessment.
• Forced expiratory volume in 1 second (FEV1) /forced vital capacity (FVC) ratio ≥ 60% as determined by spirometry adhering to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.
Locations
Other Locations
Canada
Dynamic Drug Advancement Ltd
RECRUITING
Ajax
BLC Clinical Research
RECRUITING
Burlington
Recherche GCP Research
RECRUITING
Montreal
Medical Arts Health Research Group - North Vancouver
RECRUITING
North Van Couver
Clinique Specialisee En Allergie De La Capitale
RECRUITING
Québec
Diex Recherche - Quebec
RECRUITING
Québec
Clinque DE Pneumologie ET Du Sommeil DE Lanaudiere
RECRUITING
Saint-charles-borromée
Centre D'Investigation Clinique Mauricie Inc (CIC Mauricie)
RECRUITING
Trois-rivières
Diex Recherche-Victoriaville
RECRUITING
Victoriaville
Fadia El Boreky Medicine Prof. Corp.
RECRUITING
Waterloo
Contact Information
Primary
Paula Buckley
Paula.Buckley@trevitherapeutics.com
(203) 304-2499
Backup
Connie Crum
Time Frame
Start Date:2026-06-22
Estimated Completion Date:2027-09
Participants
Target number of participants:100
Treatments
Experimental: NAL ER 54 mg BID
Participants will receive NAL ER during the titration period, with dose titration starting at 27 milligrams (mg) once daily (QD) and increasing up to 54 mg twice daily (BID) from Day 1 to Day 14. Participants will receive NAL ER 54 mg BID during the fixed-dose treatment period from Day 15 to Day 42.
Experimental: NAL ER 27 mg BID
Participants will receive NAL ER during the titration period, starting at 27 mg QD to 27 mg BID from Day 1 to Day 14. Participants will receive NAL ER 27 mg BID during the fixed-dose treatment period from Day 15 to Day 42.
Experimental: NAL ER 27 mg QD
Participants will receive NAL ER 27 mg QD during the titration period from Day 1 to Day 14. Participants will continue to receive NAL ER 27 mg QD during the fixed-dose treatment period from Day 15 to Day 42.
Placebo_comparator: Placebo
Participants will receive matching placebo during the titration period from Day 1 to Day 14 and the fixed-dose treatment period from Day 15 to Day 42.