Phase II Study, Randomized, Double-Blind, Placebo-Controlled 4-Week Clinical Study, to Evaluate the Efficacy and Safety of MK-7264 in Adult Japanese Participants With Unexplained or Refractory Chronic Cough
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 16
- 主要终点
- Number of Participants Who Experienced an Adverse Event
研究概览
简要总结
This estimation study (no hypotheses) will evaluate the safety, tolerability, and efficacy of gefapixant (MK-7264) in Japanese adult participants with unexplained or refractory chronic cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator.
- •Has had chronic cough for ≥ 1 year and a diagnosis of refractory chronic cough or unexplained chronic cough.
- •For female participants, is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
- •Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)
排除标准
- •Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with a pack-year history >20 pack-years
- •Has a history of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status
- •Has a history of chronic bronchitis
- •Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
- •Has a history of malignancy ≤5 years
- •Has a screening systolic blood pressure >160 millimeters of mercury (mmHg) or a diastolic blood pressure >90 mm Hg
- •Has a history of cutaneous adverse drug reaction to sulfonamides with or without systemic symptoms or history of anaphylaxis to sulfonamides
- •Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
- •Has a known allergy/sensitivity or contraindication to gefapixant
- •Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
- •Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study
研究组 & 干预措施
Gefapixant 45 mg
Participants will receive a gefapixant 45 mg film-coated tablet BID for 28 days.
干预措施: Gefapixant 45 mg (Drug)
Placebo
Participants will receive a film-coated placebo tablet matching gefapixant BID for 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event
时间窗: Up to 6 weeks
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
时间窗: Up to 4 weeks
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
次要结局
- Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour(Baseline and Week 4)
- Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour(Baseline and Week 4)