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.
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.
Clinical diagnosis of sleep apnea and/or use of continuous positive airway pressure (CPAP).
Upper or lower respiratory tract infection or change in pulmonary status in the 4 weeks prior to the Screening visit or during the Screening or PBO Run-in periods.
History of bronchiectasis, chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF), or other significant respiratory disorder that might affect cough.
≥1 clinically significant exacerbation in the last 6 months, OR
Parallel
NAL ER
DrugOral tablets
Placebo
DrugOral tablets
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
Relative Change From Baseline in 24-hour Cough Frequency
Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction in 24-hour Cough Frequency
Change From Baseline in Patient Reported Cough Frequency (PR-CF)
Change From Baseline in Cough Severity Visual Analog Scale (CS-VAS)
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