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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 61
- 主要终点
- Number of Participants Who Experienced at Least One Adverse Event (AE)
研究概览
简要总结
The primary objective of this study is to evaluate the safety of two doses of gefapixant (MK-7264) in Japanese adult participants with refractory or unexplained 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 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.
- •Chronic cough for ≥ 4 months and a diagnosis of refractory or unexplained chronic cough.
- •Persistent cough, despite treatment in accordance with the latest guideline of cough from the Japanese Respiratory Society, cough is a burden to the participant, 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.
排除标准
- •Current smoker, or has given up smoking within 12 months of Screening.
- •History of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status.
- •Has a history of chronic bronchitis.
- •Current use of an angiotensin converting enzyme inhibitor (ACEI) or has taken an ACEI within 3 months of Screening.
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 OR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Visit 1 with unstable renal function (defined as a ≥50% increase of serum creatinine compared to a value obtained at least 6 months prior to Visit 1).
- •History of malignancy ≤ 5 years.
- •User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
- •Systolic blood pressure >160 mm Hg or a diastolic blood pressure >90 mm Hg at Screening.
- •History of cutaneous adverse drug reaction to sulfonamide antibiotics or other sulfonamide-containing drugs.
- •Known allergy/sensitivity or contraindication to gefapixant.
- •Donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant.
- •Previously received gefapixant or is currently participating in or has participated in an interventional clinical study.
研究组 & 干预措施
Gefapixant 15 mg BID
Participants will receive gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg twice daily (BID) during the study period (52 weeks).
干预措施: Gefapixant (Drug)
Gefapixant 15 mg BID
Participants will receive gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg twice daily (BID) during the study period (52 weeks).
干预措施: Placebo (Drug)
Gefapixant 45 mg BID
Participants will receive gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the study period (52 weeks).
干预措施: Gefapixant (Drug)
Gefapixant 45 mg BID
Participants will receive gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the study period (52 weeks).
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced at Least One Adverse Event (AE)
时间窗: Up to 54 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinued Study Drug Due to an AE
时间窗: Up to 52 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
次要结局
- Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score(Baseline, Up to 52 Weeks)
- Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12(Baseline, Week 12)
- Change From Baseline in LCQ Total Score(Baseline, up to 52 Weeks)