A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chr… (NCT03696108) | Clinical Trial Compass
CompletedPhase 3
A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)
Japan175 participantsStarted 2018-10-31
Plain-language summary
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.
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)…
What they're measuring
1
Number of Participants Who Experienced at Least One Adverse Event (AE)
Timeframe: Up to 54 Weeks
2
Number of Participants Who Discontinued Study Drug Due to an AE