MedTrace Logo

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

NCT04193176 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2024-11-05

Study results available
· View outcomes & findings →

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

DRUG

Gefapixant

Administered twice daily as an oral tablet of 45 mg

DRUG

Placebo

Administered twice daily as a placebo oral tablet matching gefapixant

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-10
Primary Completion
2022-08-18
Completion
2022-09-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Colombia
  • Germany
  • Guatemala
  • Israel
  • Peru
  • Russia
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04193176 on ClinicalTrials.gov