CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 161 enrolled
Drug / intervention
Gefapixant 45 mg twice daily (BID) +3 moredrug
Likely dose
Gefapixant 45 mg twice daily (BID)from 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/NCT04525885
NCT04525885Phase 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 Aug 25, 2020·Updated Jan 12, 2024

In Brief

A Phase 3 clinical trial evaluating Gefapixant 45 mg twice daily (BID), Gefapixant 15 mg BID, and 2 other interventions for Chronic Cough. Completed, enrolled 161 participants across 8 sites.

Detailed Summary

The primary objective of this study will be to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period. It is hypothesized 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
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 25, 2020
Enrollment StartMay 17, 2019
Primary CompletionSep 15, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.9 years ago

Interventions

Gefapixant 45 mg twice daily (BID)drug

Gefapixant 45 mg tablet to be administered orally BID

Gefapixant 15 mg BIDdrug

Gefapixant 15 mg tablet to be administered orally BID

Placebodrug

Placebo tablet administered orally BID

Gefapixant 45 mg BIDdrug

Gefapixant 45 mg tablet to be administered orally BID