Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
Status and phase
Completed
Phase 3
Conditions
Chronic Cough
Treatments
Drug: Gefapixant
Drug: Placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
376 patients
Sex
Female
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
376 participants in 2 patient groups, including a placebo group
Gefapixant
Experimental group
Description:
Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Treatment:
Drug: Gefapixant
Placebo
Placebo Comparator group
Description:
Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Treatment:
Drug: Placebo
Trial contacts and locations
90
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Data sourced from clinicaltrials.gov
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