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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Cough

In brief

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.

Key facts

Study ID

NCT04193176

Run by

Merck Sharp & Dohme LLC

People needed

376

Starts

2020-05-10

Expected to finish

2022-09-02

Last updated by the study team

2024-11-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Health Awareness, Inc. ( Site 0038) — Jupiter, Florida, United States
• Well Pharma Medical Research, Corp. ( Site 0040) — Miami, Florida, United States
• Lenus Research & Medical Group Llc ( Site 0007) — Sweetwater, Florida, United States
• Florida Pulmonary Research Institute, LLC ( Site 0008) — Winter Park, Florida, United States
• Paul A. Shapero, MD ( Site 0037) — Bangor, Maine, United States
• Chesapeake Clinical Research, Inc ( Site 0022) — White Marsh, Maryland, United States
• University of Missouri ENT & Allergy Center ( Site 0010) — Columbia, Missouri, United States
• Alliance for Multispecialty Research, LLC ( Site 0035) — Las Vegas, Nevada, United States
• Albuquerque Clinical Trials ( Site 0019) — Albuquerque, New Mexico, United States
• American Health Research ( Site 0027) — Charlotte, North Carolina, United States
• Clinical Research of Gastonia ( Site 0016) — Gastonia, North Carolina, United States
• PMG Research of Wilmington ( Site 0004) — Wilmington, North Carolina, United States
• Temple University ( Site 0003) — Philadelphia, Pennsylvania, United States
• AAPRI Clinical Research Institute ( Site 0031) — Warwick, Rhode Island, United States
• Diagnostics Research Group ( Site 0013) — San Antonio, Texas, United States
• TPMG Clinical Research ( Site 0025) — Newport News, Virginia, United States
• Tidewater Physician Multispecialty Group, PC ( Site 0028) — Williamsburg, Virginia, United States
• Bellingham Asthma & Allergy ( Site 0006) — Bellingham, Washington, United States
• Centro Medico Dra De Salvo ( Site 0300) — Buenos Aires, Argentina
• Investigaciones en Patologias Respiratorias ( Site 0302) — San Miguel de Tucumán, Argentina
• Fundacion Centro de Investigacion Clinica CIC ( Site 0401) — Medellín, Antioquia, Colombia
• Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408) — Medellín, Antioquia, Colombia
• Medplus Medicina Prepagada ( Site 0402) — Bogotá, Bogota D.C., Colombia
• Healthy Medical Center S.A.S ( Site 0404) — Zipaquirá, Cundinamarca, Colombia
• Center for Clinical Trials, LLC ( Site 0021) — Paramount, California, United States

Full record on ClinicalTrials.gov

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