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

SHIONOGI & CO., LTD.0 个研究点目标入组 372 人开始时间: 2019年12月20日最近更新: 2023年10月17日

试验速览

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•Key Inclusion Criteria:
•-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.

•Key Exclusion Criteria:
•-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 symptoms (excluding cough).
•-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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