NCT03449147

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,317 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Cough

Interventions

Type	Name	Description
DRUG	Placebo	Placebo tablet administered orally BID
DRUG	Gefapixant 15 mg BID	Gefapixant 15 mg tablet administered orally BID
DRUG	Gefapixant 45 mg BID	Gefapixant 45 mg tablet administered orally BID

Timeline

• Start date: 2018-03-15
• Primary completion: 2020-08-20
• Completion: 2020-10-30
• First posted: 2018-02-28
• Last updated: 2021-09-02
• Results posted: 2021-09-02

Locations

171 sites across 20 countries: United States, Australia, Canada, China, Colombia, Czechia, Denmark, Germany, Guatemala, Hungary, Israel, Italy, Malaysia, New Zealand, Peru, Poland, South Africa, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study