A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN027)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN027)
The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.
The study will include a screening period to determine participant inclusion, and the Baseline visit will include 24 hours of objective measurement of cough. The study will consist of two treatment periods, a main 12-week treatment period and a 40-week extension period (52 weeks total treatment), followed by a 14-day telephone follow-up period.
Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 3-month, Off-treatment Durability Study Period, which extends the Estimated Study Completion Date. The Off-treatment Durability Study Period will explore the impact of withdrawing gefapixant in refractory or unexplained chronic cough participants who have been treated for 1 year.
Inclusion Criteria:
Exclusion Criteria:
East Providence, Rhode Island 02914, United States
Charlottesville, Virginia 22911, United States
Caba, Buenos Aires C1425BEN, Argentina
Ciudad de Buenos Aires, Buenos Aires C1121ABE, Argentina
San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina
San Miguel de Tucumán, Tucumán Province T4000IAR, Argentina
Naka-gun, Ibaraki 319-1113, Japan
Tsukubo-gun, Okayama-ken 701-0304, Japan
Sakai, Osaka 591-8555, Japan
Shizuoka, 420-8527, Japan
Tokyo, 162-8655, Japan
Fatih, 34098, Turkey (Türkiye)
Istanbul, 34020, Turkey (Türkiye)
Rize, 55200, Turkey (Türkiye)
Corby, Northamptonshire NN17 2UR, United Kingdom