A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)

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追踪信息

首次提交日期 ^ICMJE

October 3, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 15, 2018

预计主要完成日期

October 1, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Adverse Events (AEs)[ Time Frame: Up to 54 weeks ]

The number (or percentage) of participants experiencing at least one AE will be reported.

Discontinuation Due to an AE[ Time Frame: Up to 52 weeks ]

The number (or percentage) of participants discontinuing study drug due to an adverse event will be reported.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score[ Time Frame: Baseline, Week 12, up to Week 52 ]
Participants will be asked to complete the 19-item LCQ to assess the symptoms or the impact of symptoms on health-related quality of life (HRQoL) over the past two weeks using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL.

描述性信息

简略标题 ^ICMJE

A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)

正式标题 ^ICMJE

A Phase 3, Randomized, Double-blind Clinical Study to Evaluate the Long-term Safety and Efficacy of MK-7264 in Japanese Adult Participants With Refractory or Unexplained Chronic Cough

简要概况

The primary objective of this study is to evaluate the number of adverse events (AEs)and discontinuation due to AEs through up to 52 weeks of treatment with gefapixant in Japanese adult participants with refractory or unexplained chronic cough.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 3

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Gefapixant
Participants will receive a gefapixant 15 mg or 45 mg tablet administered orally BID
Drug: Placebo
Participants will receive a matching placebo tablet administered orally BID

研究工具

Experimental: Geapixant 45 mg BID
Participants will receive a gefapixant 45 mg film-coated tablet twice daily (BID) during the study period (52 weeks).
Experimental: Gefapixant 15 mg BID
Participants will receive a gefapixant 15 mg film-coated tablet BID during the study period (52 weeks).
Placebo Comparator: Placebo
Participants will receive a matching placebo tablet BID during the study period (52 weeks).

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

160

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 6, 2020

预计主要完成日期

October 1, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Has a chest radiograph or computed tomography scan of the thorax 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 ≥ 4 months and a diagnosis of refractory or unexplained chronic cough. - Has persistent cough despite of treatment in accordance with the latest guideline of cough from the Japanese Respiratory Society and is burdened and needs further treatment. - If female, is not pregnant, not breast-feeding, and either is not a woman of childbearing potential or agrees to follow the contraceptive guidance. - Is able to provide written informed consent and is willing and able to comply with all aspects of the study protocol. Exclusion Criteria: - Is a current smoker, or has given up smoking within 12 months of Screening. - Has a hstory 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 taken an ACEI within 3 months of Screening. - Has an estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m^2 (using the Japanese Equation for Estimating GFR [Japanese Society of Nephrology]) at Screening. - Has a history of malignancy ≤ 5 years. - Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. - Has a systolic blood pressure >160 mm Hg or a diastolic blood pressure >90 mm Hg at Screening. - Has a history of cutaneous adverse drug reaction to sulfonamides antibiotics or other sulfonamide-containing drugs. - 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.

性别

参与研究的性别:

All

年龄

最小年龄：20 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Yes

责任方

，

研究赞助商 ^ICMJE

Merck Sharp & Dohme Corp.

合作者 ^ICMJE

研究员 ^ICMJE

Study Director: Medical Director Merck Sharp & Dohme Corp.

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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