Phase 3
N=376
Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
Chronic Cough
Bottom Line
View on ClinicalTrials.gov: NCT04193176 ↗Enrolled (actual)
376
Serious AEs
1.3%
Results posted
Sep 2023
Primary outcome: Primary: Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12 — -41.09; -52.78 Percent Change — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gefapixant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12 |
-41.09; -52.78 | 0.004 sig |
| SECONDARY Percentage of Participants With Adverse Events |
37.4; 69.7 | — |
| SECONDARY Percentage of Participants Who Discontinued Study Intervention Due to AEs |
1.1; 7.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04193176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.