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.
- Conditions
- Refractory chronic coughMedDRA version: 21.1Level: LLTClassification code 10066656Term: Chronic coughSystem Organ Class: 100000004855Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2019-002283-27-PL
- Lead Sponsor
- Shionogi B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 372
-Male or female outpatient =18 to =80 years of age at the time of signing the informed consent form.
-Has refractory chronic cough lasting for at least 1 year prior to Visit 1, defined as: insufficient improvement in cough after treatment for the underlying condition(s) causing the cough OR unexplained cough for which an underlying condition has not been determined
-With severity of cough assessed as =40 mm on the Visual Analog Scale (VAS) at both Visit 1 and Visit 2.
-With cough count =10 times per hour based on the 24- hour cough count recording at Visit 1. (Results will be available by Visit 2; no calculation is necessary).
-If female, agreement to use one of the following contraceptive methods from screening until 14 days after the last dose of study drug UNLESS the patient is surgically sterile by hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy or tubal ligation with appropriate documentation of such surgery or postmenopausal (defined as at least 12 months of spontaneous amenorrhea in women >45 years of age).
Progestogen-only oral hormonal contraception (where inhibition of ovulation is not the primary mode of action), male or female condom with or without spermicide, cap, diaphragm, or sponge with spermicide.
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
- 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 (COPD) or, as defined in the Global Initiative for Asthma (GINA) 2019, has 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.
- With any finding on a chest x-ray or chest CT scan (performed not more than 1 year prior to Visit 1 after onset of chronic cough at Visit 1) that could be considered the cause of chronic cough or indicative of lung disease. (If a chest x- ray or chest CT scan needs to be performed, results will be available by Visit 2.) (Note: Patients with abnormal chest image findings not considered to be the cause of chronic cough are eligible to participate.)
- 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method