None listed
Conditions
Interventions
Gefapixant Type of group
Placebo tablet, identical to Gefapixant 45mg, oral administration, twice daily (BID) for 12 weeks.
Sponsors
Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 1.Has a chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease, in the opinion of the principal investigator or subinvestigator. 2.Has a chronic cough (defined as duration of >8 weeks after onset of symptoms) for ≥12 months. 3.Has a diagnosis of refractory chronic cough or unexplained chronic cough. 4.Has a score of ≥40 mm on the Cough Severity VAS at Screening/Visit 1 and Placebo Run-in/Visit 2. 5.Presenta sintomas de SUI, definida como perdida involuntaria de orina que se produce a causa de esfuerzo, esfuerzo fisico o al estornudar o toser, durante ≥3 meses. 5.Has symptoms of SUI, defined as involuntary loss of urine on effort, physical exertion, or on sneezing or coughing, for ≥ 3 months. 6.Has pure or predominant SUI. 7.Has a history of cough-induced SUI. 8.Has, on average, ≥ 2 cough-induced SUI episodes per day during each 7-day period prior to Placebo Run-in/Visit 2 and Randomization/Visit 3, as measured by the Incontinence Diary. 9.Has a positive cough stress test at Screening/Visit 1. 10.Is female, 18 years of age or older, at the time of signing the informed consent. 11.Has a body mass index of ≤ 40 kg/m2. 12.A female participant is eligible to participate if she is not pregnant or breastfeeding. 13.Provides written informed consent for the study (or legally acceptable representative, if applicable). The participant may also provide consent for future biomedical research. However, the participant may participate in the study without participating in future biomedical research. 14.Demonstrates compliance with the Incontinence Diary completion requirements, as evidenced by fully completing the diary for at least 4 of the 7 days prior to Visit 2 (Screening period) and at least 4 of the 7 days prior to Randomization/Visit 3 (Placebo Run-in period). 15.Is willing and able to comply with all aspects of the protocol, including agreeing not to smoke during the study and demonstrating an ability to follow study procedures (including completion of the I-QoL, CSD, and Cough Severity VAS) to the satisfaction of the investigator/qualified designee prior to randomization.
Exclusion criteria
Exclusion criteria: 1.Is a current smoker. 2.Has given up smoking within 12 months of Screening/Visit 1. 3.Is a former smoker with a smoking history greater than 20 pack-years (eg, 1 pack [20 cigarettes] per day for 20 years). 4.Has a FEV1/ FVC ratio <60% (spirometry performed within the past year is acceptable if the investigator confirms that the spirometry was done during a period where the participant was clinically stable, eg, not during an upper respiratory infection). 5.Has a history of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status within 4 weeks of Screening/Visit 1. 6.Has a history of chronic bronchitis, defined as a cough that produces a clinically significant amount of sputum (greater than approximately 1 tablespoon of phlegm) that occurs every day for at least 3 months in a row, with those periods occurring at least 2 years in a row. 7.Has a history of surgery to treat SUI within 1 year of the Screening/Visit 1. 8.Has a history of other specialized treatments for SUI, including intravesical balloon or urethral bulking agent therapy. 9.Has a pessary or other external incontinence device currently or within 1 month of the Screening/Visit 1. 10.Has a history of Grade 3 or higher pelvic organ prolapse previously documented (unless corrected by surgery at least 1 year prior to Screening) or diagnosed on screening examination. 11.Has a neurogenic bladder. 12.Has unexplained hematuria (gross or microscopic) or has dysuria at Screening/Visit 1. 13.Has a history of adult nocturnal incontinence. 14.Has a history of continuous urine leakage within 1 month of the Screening/Visit 1. 15.Has a history of interstitial cystitis. 16.Has a history of clinically significant neurological disease (including stroke) or injury that could affect the lower urinary tract or its nerve supply. 17.Has active or recurrent urinary tract infection. 18.Has a history of having a permanent urinary catheter (at any time) or any urinary catheterization within 3 months of the Screening/ Visit 1. 19.Has an eGFR <30 mL/min/1.73 m2 at Screening/Visit 1 OR eGFR ≥30 mL/min/1.73 m2 and <50 mL/min/1.73 m2 at Screening/Visit 1 with unstable renal function (defined as a ≥50% increase of serum creatinine compared to a value obtained at least 6 months prior to Screening/Visit 1). 20.Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. 21.Is, at the time of signing the informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. 22.Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs. 23.Has a known allergy/sensitivity or contraindication to gefapixant or its excipients (Note: refer to the IB for details regarding excipients for gefapixant). 24.Has donated or lost ≥1 unit of blood (approximately 300 mL) within 8 weeks prior to the first dose of gefapixant. 25.Is a WOCBP who has a positive urine pregnancy test at Screening/Visit 1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 26.Requires treatment with a therapy for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Longitudinal ANCOVA Model. Measure:Episodes of cough-induced stress urinary incontinence (SUI). Timepoints:Episodes will be recorded for the seven days prior to randomization and for the 7 days prior to each visit at weeks 4, 8, and 12 after randomization. ; Outcome name:Miettinen and Nurminen method Measure:Proportion of adverse events (AE) and Discontinuation of study intervention due to AEs Timepoints:From the time of intervention allocation/ randomization through 14 days following cessation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:N/A Measure:N/A Timepoints:N/A | — |
Countries
Argentina, Germany, Guatemala, Israel, Korea South, Peru, Russian Federation, Spain, Ukraine, United Kindgdom, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed