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Completed

NCT Number: NCT03696108

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

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.

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Key information

Conditions

Chronic Cough Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu Rosai Hospital ( Site 3839), Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Gefapixant

Drug

Gefapixant 15 mg or 45 mg tablet administered orally BID

Other names: MK-7264

Placebo

Drug

Placebo matched to gefapixant 15 mg or 45 mg administered orally BID

Primary outcomes

  1. Number of Participants Who Experienced at Least One Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Who Discontinued Study Drug Due to an AE

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12

    Time frame: Baseline, Week 12

    The LCQ is a 19-item cough-specific health-related quality of life (HRQoL) questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model.

  2. Change From Baseline in LCQ Total Score

    Time frame: Baseline, up to 52 Weeks

    The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model at weeks 4, 8, 12, 24, 38 and 52 of treatment.

  3. Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score

    Time frame: Baseline, Up to 52 Weeks

    The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at weeks 4, 8, 12, 24, 38 and 52 of treatment.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2018
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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