Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incont… (NCT04193176) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
United States376 participantsStarted 2020-05-10
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has a chest radiograph or computed tomography scan of the thorax (within 5 years of Screening and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other lung disease
* Has chronic cough (defined as duration of \>8 weeks after onset of cough symptoms) for ≥12 months
* Has a diagnosis of refractory chronic cough or unexplained chronic cough
* Has symptoms of SUI, defined as involuntary loss of urine on effort, physical exertion, or on sneezing or coughing, for ≥3 months
* Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
Exclusion Criteria:
* Is a current smoker
* Has given up smoking within 12 months of screening
* Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
* Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
* Has a history of chronic bronchitis
* Has a history of surgery to treat SUI within 1 year of screening
* Has a history of other specialized treatments for SUI, including intravesical balloon or urethral bulking agent therapy
* Has other external incontinence device currently or within 1 month of screening
* Has a history of Grade 3 or higher pelvic organ prolapse previously documented or diagnosed on screening
* Has a neurogenic bladder
* Has a history…
What they're measuring
1
Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12