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 (PN030)
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 (PN030)
The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.
This study will have a main 24-week treatment period and a 28-week extension period of treatment (total treatment period of 52 weeks). Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 12-week, Off-treatment Durability Study Period. Any assessments conducted in the observational period will be exploratory.
Inclusion Criteria:
Exclusion Criteria:
San Jose, California 95117, United States
Ypsilanti, Michigan 48197, United States
Saint-Charles-Borromée, Quebec J6E 2B4, Canada
Guangzhou, Guangdong 510120, China
MedellÃn, Antioquia 050036, Colombia
Bogota, Cundinamarca 110311, Colombia
Bogota, Cundinamarca 111831, Colombia
MedellÃn, 050010, Colombia
Jindrichuv Hradec III, 377 01, Czechia
Neu-Isenburg, 63263, Germany
Umhlanga Ridge, KwaZulu-Natal 4319, South Africa
Edirne, 22030, Turkey (Türkiye)
Istanbul, 34093, Turkey (Türkiye)
Izmir, 35110, Turkey (Türkiye)
Cottingham, East Yorkshire HU16 5JQ, United Kingdom
Birmingham, Edgbaston B15 2SQ, United Kingdom
Northwood, Middlesex HA6 2RN, United Kingdom
Corby, Northamptonshire NN17 2UR, United Kingdom
Kenilworth, Warwickshire CV8 1JD, United Kingdom