Last updated on August 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Cough
  • Age: Between 20 - 100 Years
  • Gender: Male or Female

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) <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 (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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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