A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Women With Chronic Cough and Stress Urinary Incontinence

CompletadoFase 3ClinicalTrials.gov

ID: NCT04193176Tipo: INTERVENTIONALInicio: 10 de may de 2020Fin estimado: 2 de sept de 2022

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Gefapixant

Administered twice daily as an oral tablet of 45 mg

drug

Placebo

Administered twice daily as a placebo oral tablet matching gefapixant

Ubicaciones

Centro Medico Dra De Salvo ( Site 0300)

Buenos Aires, Argentina

Investigaciones en Patologias Respiratorias ( Site 0302)

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

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