At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough
In Brief
A Phase 3 clinical trial evaluating Gefapixant and Placebo for Chronic Cough. Completed, enrolled 419 participants across 91 sites in 12 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration \>8 weeks after onset of cough symptoms) for \<12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.
Study Details
Timeline
Interventions
Administered twice daily as an oral tablet of 45 mg
Administered twice daily as a placebo oral tablet matching gefapixant