NCT03449134

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 732 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Cough

Interventions

Type	Name	Description
DRUG	Placebo	Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.
DRUG	Gefapixant	Gefapixant 15 mg or 45 mg tablet administered orally BID during the 12-week main study period and during the 40-week extension period, according to randomization.

Timeline

• Start date: 2018-03-14
• Primary completion: 2020-06-05
• Completion: 2020-08-17
• First posted: 2018-02-28
• Last updated: 2021-06-16
• Results posted: 2021-06-16

Locations

156 sites across 17 countries: United States, Argentina, Canada, Czechia, Denmark, France, Hungary, Israel, Japan, Peru, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study