Research study of an investigational drug called S-600918 for refractory chronic cough, defined as chronic cough that continues after treatment for the disease(s) causing the cough or as unexplained chronic cough for which the disease has not been determined.

Phase 1

• Conditions: Refractory chronic cough; MedDRA version: 21.1Level: LLTClassification code 10066656Term: Chronic coughSystem Organ Class: 100000004855; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2019-002283-27-GB
• Lead Sponsor: Shionogi B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-18
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 372

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.
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

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 (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 clinical trial of medicinal product
• Study Design: Not specified