EUCTR2019-002283-27-PL进行中（未招募）1 期
A phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-selection study of S-600918 in patients with refractory chronic cough
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 372
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-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
排除标准
- •- 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 >
- •- 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.
研究者
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