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

NCT04193176 ↗

Phase 3 Completed 376 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2020-05-10
Primary completion: 2022-08-18
Completion: 2022-09-02

Publications

Results Birring SS, Cardozo L, Dmochowski R, Dicpinigaitis P, Afzal A, La Rosa C, Lu S, Nguyen AM, Yao R, Reyfman PA. Efficacy and safety of gefapixant in women with chronic cough and cough-induced stress urinary incontinence: a phase 3b, randomised, multicentre, double-blind, placebo-controlled trial. Lancet Respir Med. 2024 Nov;12(11):855-864. doi: 10.1016/S2213-2600(24)00222-4. Epub 2024 Aug 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gefapixant	Small molecule	45 mg	Oral

Indications

No indication recorded.