Evaluation of S-600918 in Adults With Refractory Chronic Cough (NCT04110054) | Clinical Trial Compass
CompletedPhase 2
Evaluation of S-600918 in Adults With Refractory Chronic Cough
United States406 participantsStarted 2020-02-13
Plain-language summary
The primary objective of this study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.
* 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 …
What they're measuring
1
Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study Treatment