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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

October 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^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

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^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

Study Arms

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).

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

160

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 6, 2020

Estimated Primary Completion Date

October 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Yes

Responsible Party

，

Study Sponsor ^ICMJE

Merck Sharp & Dohme Corp.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Medical Director Merck Sharp & Dohme Corp.

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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