A phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose selection study of S-600918 in patients with refractory chronic cough

Shionogi B.V.0 个研究点目标入组 372 人开始时间: 2019年11月18日最近更新: 2020年5月4日

研究概览

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•- Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
•- If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
•- Capable of giving signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 360
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•- Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
•- Has chronic obstructive pulmonary disease or uncontrolled asthma.
•- Has a clinically unstable medical condition.
•- History of or ongoing significant psychiatric disorder.
•- History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
•- History of malignancy in the last 5 years.
•- History of severe drug allergy.
•- History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
•- Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
•- Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
•- Received S-600918 previously.
•- Received an investigational drug in the last 3 months.
•- Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
•- Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
•- If female, pregnant or trying to become pregnant or breastfeeding.

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