Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033)

Merck Sharp & Dohme LLC23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Cough

Interventions

Gefapixant 45 mgDRUG

Gefapixant 45 mg (film-coated tablet) to be administered orally BID

PlaceboDRUG

Placebo (film-coated tablet) matching gefapixant to be administered orally BID

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Locations (16)

Nagoya City University Hospital ( Site 3328)

Nagoya, Aichi-ken, Japan

Idaimae Minamiyojo Int Clinic ( Site 3321)

Sapporo, Hokkaido, Japan

Outcomes

Primary Outcomes

Number of Participants Who Experienced an Adverse Event

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.

Time frame: Up to 6 weeks

Number of Participants Who Discontinued Study Treatment Due to an Adverse Event

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.

Time frame: Up to 4 weeks

Secondary Outcomes

Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour

Cough frequency will be evaluated using a digital recording device which records sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. Change from baseline in log-transformed 24-hour coughs per hour = log (24-hour coughs per hour at post-baseline) - log (24-hour coughs per hour at baseline). The denominators may be different if the recording period is actually \<24 hours but ≥20 hours).

Time frame: Baseline and Week 4

Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour

Change from baseline at Week 4 in awake coughs per hour is the average hourly cough frequency (based on sound recordings) during the 24-hour monitoring period while the participant is awake. Change from baseline in log-transformed awake coughs per hour = log (awake coughs per hour at post-baseline) - log (awake coughs per hour at baseline) for the monitoring period the participant is awake.

Time frame: Baseline and Week 4

Data from ClinicalTrials.gov

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