Evaluation of S-600918 in patients with refractory chronic cough

Phase 2

Completed

• Conditions: Refractory chronic cough

• Registration Number: JPRN-jRCT2080224991
• Lead Sponsor: SHIONOGI & CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-20
• Study Completion: 2020-12-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified