Status:
COMPLETED
Evaluation of S-600918 in Adults With Refractory Chronic Cough
Lead Sponsor:
Shionogi
Conditions:
Chronic Cough
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2020
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT04110054
Start Date
February 13 2020
End Date
December 28 2020
Last Update
March 27 2024
Active Locations (136)
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1
Research Solutions of Arizona
Litchfield Park, Arizona, United States, 85340
2
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85032
3
Alliance for Multispecialty Research
Tempe, Arizona, United States, 85283
4
Southern California Institute For Respiratory Diseases, Inc.
Los Angeles, California, United States, 90048