CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,317 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Gefapixant 15 mg BIDfrom 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/NCT03449147
NCT03449147Phase 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 (PN030)

Merck Sharp & Dohme LLC·interventional·Posted Feb 28, 2018·Updated Sep 2, 2021

In Brief

A Phase 3 clinical trial evaluating Placebo, Gefapixant 15 mg BID, and 1 other intervention for Chronic Cough. Completed, enrolled 1,317 participants across 171 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Cough
CountriesAustralia, Canada, China, Colombia, Czechia, Denmark, Germany, Guatemala, Hungary, Israel, Italy, Malaysia, New Zealand, Peru, Poland, South Africa, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 28, 2018
Enrollment StartMar 15, 2018
Primary CompletionAug 20, 2020
Study CompletionOct 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.3 years ago

Interventions

Placebodrug

Placebo tablet administered orally BID

Gefapixant 15 mg BIDdrug

Gefapixant 15 mg tablet administered orally BID

Gefapixant 45 mg BIDdrug

Gefapixant 45 mg tablet administered orally BID