CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 732 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Gefapixant 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03449134
NCT03449134Phase 3Completed
CompareCT.gov

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)

Merck Sharp & Dohme LLC·interventional·Posted Feb 28, 2018·Updated Jun 16, 2021

In Brief

A Phase 3 clinical trial evaluating Placebo and Gefapixant for Chronic Cough. Completed, enrolled 732 participants across 156 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Cough
CountriesArgentina, Canada, Czechia, Denmark, France, Hungary, Israel, Japan, Peru, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 28, 2018
Enrollment StartMar 14, 2018
Primary CompletionJun 5, 2020
Study CompletionAug 17, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.3 years ago

Interventions

Placebodrug

Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.

Gefapixantdrug

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.