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

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 of adult nocturnal incontinence
• Has a history of continuous urine leakage within 1 month of screening
• Has a history of interstitial cystitis
• Has a history of neurological disease or injury
• Has active or recurrent urinary tract infection
• Has a history of having a permanent urinary catheter or any urinary catheterization within 3 months of screening
• Has a history of malignancy ≤5 years prior to signing informed consent
• Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
• Has a known allergy to gefapixant or its excipients
• Has donated or lost ≥1 unit (~300 mL) of blood within 8 weeks prior to first dose of gefapixant
• Requires certain medications and/or other therapies that may impact their cough or bladder function
• Has previously received gefapixant
• Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study