At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 376 enrolled
Drug / intervention
Gefapixant +1 moredrug
Likely dose
Gefapixant 45 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.
A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Women With Chronic Cough and Stress Urinary Incontinence
In Brief
A Phase 3 clinical trial evaluating Gefapixant and Placebo for Chronic Cough. Completed, enrolled 376 participants across 90 sites in 12 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of gefapixant, in improving symptoms of cough-induced stress urinary incontinence (SUI) in adult female participants with refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in reducing the frequency of cough-induced SUI episodes over 12 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Cough
CountriesArgentina, Colombia, Germany, Guatemala, Israel, Peru, Russia, South Korea, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartMay 2020
Primary CompletionAug 2022
Study CompletionSep 2022
TodayJul 2026
First PostedDec 10, 2019
Enrollment StartMay 10, 2020
Primary CompletionAug 18, 2022
Study CompletionSep 2, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.6 years ago
Interventions
Gefapixantdrug
Administered twice daily as an oral tablet of 45 mg
Placebodrug
Administered twice daily as a placebo oral tablet matching gefapixant