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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
376
Administered twice daily as an oral tablet of 45 mg
Administered twice daily as a placebo oral tablet matching gefapixant
Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12
Cough-induced SUI episodes were assessed using an event-driven electronic Incontinence Diary where the participant recorded the main cause of each urinary incontinence episode as coughing, another stress reason, or other cause. Episodes of incontinence were recorded for the week before baseline and treatment visit. Average daily cough induced SUI episodes were calculated as (sum of daily cough-induced SUI episodes in a week)/number of days recorded. The percent change from baseline in the average daily cough-induced SUI episodes to Week 12 are presented.
Time frame: Baseline and week 12
Percentage of Participants With Adverse Events
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented.
Time frame: Up to ~16 weeks
Percentage of Participants Who Discontinued Study Intervention Due to AEs
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study intervention due to an adverse event are presented.
Time frame: Up to ~14 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Center for Clinical Trials, LLC ( Site 0021)
Paramount, California, United States
Health Awareness, Inc. ( Site 0038)
Jupiter, Florida, United States
Well Pharma Medical Research, Corp. ( Site 0040)
Miami, Florida, United States
Lenus Research & Medical Group Llc ( Site 0007)
Sweetwater, Florida, United States
Florida Pulmonary Research Institute, LLC ( Site 0008)
Winter Park, Florida, United States
Paul A. Shapero, MD ( Site 0037)
Bangor, Maine, United States
Chesapeake Clinical Research, Inc ( Site 0022)
White Marsh, Maryland, United States
University of Missouri ENT & Allergy Center ( Site 0010)
Columbia, Missouri, United States
Alliance for Multispecialty Research, LLC ( Site 0035)
Las Vegas, Nevada, United States
Albuquerque Clinical Trials ( Site 0019)
Albuquerque, New Mexico, United States
...and 80 more locations