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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
175
Gefapixant 15 mg or 45 mg tablet administered orally BID
Placebo matched to gefapixant 15 mg or 45 mg administered orally BID
Number of Participants Who Experienced at Least One Adverse Event (AE)
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.
Time frame: Up to 54 Weeks
Number of Participants Who Discontinued Study Drug Due to an AE
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.
Time frame: Up to 52 Weeks
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at 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.
Time frame: Baseline, Week 12
Change From Baseline in LCQ Total Score
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.
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Chubu Rosai Hospital ( Site 3839)
Nagoya, Aichi-ken, Japan
National Hospital Organization Nagoya Medical Center ( Site 3898)
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital ( Site 3899)
Nagoya, Aichi-ken, Japan
Fukuoka University Chikushi Hospital ( Site 3886)
Chikushino-shi, Fukuoka, Japan
Oishi Clinic ( Site 3818)
Kasuya-gun, Fukuoka, Japan
National Hospital Organization Fukuokahigashi Medical Center ( Site 3849)
Koga, Fukuoka, Japan
Nagata Hospital ( Site 3815)
Yanagawa, Fukuoka, Japan
Tohno Chuo Clinic ( Site 3883)
Mizunami, Gifu, Japan
National Hospital Organization Shibukawa Medical Center ( Site 3843)
Shibukawa, Gunma, Japan
Idaimae Minamiyojo Int Clinic ( Site 3903)
Sapporo, Hokkaido, Japan
...and 51 more locations
Time frame: Baseline, up to 52 Weeks
Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score
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.
Time frame: Baseline, Up to 52 Weeks