NCT04193176

Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Cough

Interventions

Type	Name	Description
DRUG	Gefapixant	Administered twice daily as an oral tablet of 45 mg
DRUG	Placebo	Administered twice daily as a placebo oral tablet matching gefapixant

Timeline

• Start date: 2020-05-10
• Primary completion: 2022-08-18
• Completion: 2022-09-02
• First posted: 2019-12-10
• Last updated: 2024-11-05
• Results posted: 2023-09-22

Locations

90 sites across 12 countries: United States, Argentina, Colombia, Germany, Guatemala, Israel, Peru, Russia, South Korea, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study