Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
- Registration Number
- NCT04193176
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 376
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks. Gefapixant Gefapixant Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12 Baseline and week 12 Cough-induced SUI episodes were assessed using an event-driven electronic Incontinence Diary where the participant recorded the main cause of each urinary incontinence episode as coughing, another stress reason, or other cause. Episodes of incontinence were recorded for the week before baseline and treatment visit. Average daily cough induced SUI episodes were calculated as (sum of daily cough-induced SUI episodes in a week)/number of days recorded. The percent change from baseline in the average daily cough-induced SUI episodes to Week 12 are presented.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events Up to ~16 weeks An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented.
Percentage of Participants Who Discontinued Study Intervention Due to AEs Up to ~14 weeks An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study intervention due to an adverse event are presented.
Trial Locations
- Locations (90)
Florida Pulmonary Research Institute, LLC ( Site 0008)
🇺🇸Winter Park, Florida, United States
Praxis Dr. Wehgartner-Winkler ( Site 0906)
🇩🇪Augsburg, Bayern, Germany
Medi Kom ( Site 1456)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Voronezh Regional Clinical Hospital #1 ( Site 1440)
🇷🇺Voronezh, Voronezskaja Oblast, Russian Federation
Hospital Clinico Universitario de Santiago ( Site 1805)
🇪🇸Santiago de Compostela, La Coruna, Spain
Hospital Clinic i Provincial de Barcelona ( Site 1804)
🇪🇸Barcelona, Cataluna, Spain
Kings College Hospital NHS Foundation Trust ( Site 2702)
🇬🇧London, Southwark, United Kingdom
Center for Clinical Trials, LLC ( Site 0021)
🇺🇸Paramount, California, United States
Lenus Research & Medical Group Llc ( Site 0007)
🇺🇸Sweetwater, Florida, United States
Health Awareness, Inc. ( Site 0038)
🇺🇸Jupiter, Florida, United States
Well Pharma Medical Research, Corp. ( Site 0040)
🇺🇸Miami, Florida, United States
Paul A. Shapero, MD ( Site 0037)
🇺🇸Bangor, Maine, United States
Chesapeake Clinical Research, Inc ( Site 0022)
🇺🇸White Marsh, Maryland, United States
Albuquerque Clinical Trials ( Site 0019)
🇺🇸Albuquerque, New Mexico, 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
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
Bellingham Asthma & Allergy ( Site 0006)
🇺🇸Bellingham, Washington, United States
Tidewater Physician Multispecialty Group, PC ( Site 0028)
🇺🇸Williamsburg, Virginia, United States
Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)
🇨🇴Medellin, Antioquia, Colombia
Centro Medico Dra De Salvo ( Site 0300)
🇦🇷Buenos Aires, Argentina
Investigaciones en Patologias Respiratorias ( Site 0302)
🇦🇷Tucuman, Argentina
Healthy Medical Center S.A.S ( Site 0404)
🇨🇴Zipaquira, Cundinamarca, Colombia
Medplus Medicina Prepagada ( Site 0402)
🇨🇴Bogota, Distrito Capital De Bogota, Colombia
Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0900)
🇩🇪Marburg, Hessen, Germany
Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0905)
🇩🇪Neu-Isenburg, Hessen, Germany
Bethel Soluciones Medicas S.A. ( Site 0506)
🇬🇹Guatemala, Guatemala
Praxis an der Oper ( Site 0912)
🇩🇪Berlin, Germany
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0500)
🇬🇹Guatemala, Guatemala
Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)
🇬🇹Guatemala, Guatemala
Sourasky Medical Center ( Site 1100)
🇮🇱Tel-Aviv, Israel
Shaare Zedek Medical Center ( Site 1107)
🇮🇱Jerusalem, Israel
Clinica Medica Especializada en Neumologia ( Site 0502)
🇬🇹Guatemala, Guatemala
Private Clinic ( Site 0505)
🇬🇹Guatemala, Guatemala
Carmel Medical Center ( Site 1104)
🇮🇱Haifa, Israel
Rabin Medical Center ( Site 1102)
🇮🇱Petah Tikva, Israel
Hadassah Ein Karem Jerusalem ( Site 1108)
🇮🇱Jerusalem, Israel
Kaplan Medical Center ( Site 1103)
🇮🇱Rehovot, Israel
Asociacion Civil por la Salud ( Site 0602)
🇵🇪Lima, Peru
Chaim Sheba Medical Center ( Site 1101)
🇮🇱Ramat Gan, Israel
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1506)
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hospital ( Site 1502)
🇰🇷Wonju-si, Kang-won-do, Korea, Republic of
Asan Medical Center ( Site 1505)
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center ( Site 1504)
🇰🇷Seoul, Korea, Republic of
Clinica Ricardo Palma ( Site 0601)
🇵🇪San Isidro, Lima, Peru
Hospital Nacional Arzobispo Loayza ( Site 0607)
🇵🇪Lima, Peru
GBUZ Regional Clinical Hospital 3 ( Site 1420)
🇷🇺Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Clinica Belen ( Site 0604)
🇵🇪Piura, Peru
City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1400)
🇷🇺Kemerovo, Kemerovskaya Oblast, Russian Federation
Krasnogorsk City Hospital Number 1 ( Site 1470)
🇷🇺Krasnogorsk, Moskovskaya Oblast, Russian Federation
Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1466)
🇷🇺Moscow, Moskva, Russian Federation
Limited Liability Company Kurator ( Site 1424)
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
SBCIH of the Yaroslavl region Central city hospital ( Site 1428)
🇷🇺Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Family Clinic ( Site 1464)
🇷🇺Yekaterinburg, Sverdlovskaya Oblast, Russian Federation
Hospital Parc Tauli ( Site 1806)
🇪🇸Sabadell, Barcelona, Spain
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2819)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Municipal enterprise "1st City clinical hospital of Poltava -Internal medicine department ( Site 281
🇺🇦Poltava, Poltavska Oblast, Ukraine
City Polyclinic N20 ( Site 2806)
🇺🇦Odesa, Odeska Oblast, Ukraine
Hospital General Universitario Gregorio Maranon ( Site 1808)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Odesa regional clinical hospital ( Site 2804)
🇺🇦Odesa, Odeska Oblast, Ukraine
Medical Center of LLC Medical Clinic Blahomed ( Site 2815)
🇺🇦Kyiv, Ukraine
GP Direct ( Site 2714)
🇬🇧Harrow, England, United Kingdom
West Walk Surgery ( Site 2700)
🇬🇧Yate, Gloucestershire, United Kingdom
Accellacare South London Quality Research Centre ( Site 2706)
🇬🇧Orpington, Surrey, United Kingdom
Medinova Lakeside Dedicated Research Centre ( Site 2712)
🇬🇧Corby, Northamptonshire, United Kingdom
Medinova Warwickshire Dedicated Research Centre ( Site 2715)
🇬🇧Coventry, United Kingdom
Medinova North London Dedicated Research Centre ( Site 2705)
🇬🇧Northwood, Worcestershire, United Kingdom
Jeonbuk National University Hospital ( Site 1507)
🇰🇷Jeonju-si, Jeonrabugdo, Korea, Republic of
Pneumologicum im Suedstadtforum ( Site 0908)
🇩🇪Hannover, Niedersachsen, Germany
Fundacion Centro de Investigacion Clinica CIC ( Site 0401)
🇨🇴Medellin, Antioquia, Colombia
Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503)
🇬🇹Guatemala, Guatemala
RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1416)
🇷🇺Belgorod, Belgorodskaya Oblast, Russian Federation
City Clinical Hospital of Emergency Care #2 ( Site 1448)
🇷🇺Novosibirsk, Novosibirskaya Oblast, Russian Federation
Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1438)
🇷🇺Omsk, Omskaya Oblast, Russian Federation
Perm Clinical Center of the Federal Medical and Biological Agency ( Site 1450)
🇷🇺Perm, Permskiy Kray, Russian Federation
State health Agency Ulyanovsk regional clinical hospital ( Site 1414)
🇷🇺Ulyanovsk, Ul Yanovskaya Oblast, Russian Federation
Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)
🇺🇦Vinnytsya, Vinnytska Oblast, Ukraine
SEIHPE Saint Petersburg SMU ( Site 1434)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1452)
🇷🇺Saratov, Saratovskaya Oblast, Russian Federation
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
SE Road Clinical Hospital 2 of Kyiv station ( Site 2812)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Wokingham Medical Centre ( Site 2708)
🇬🇧Wokingham, West Berkshire, United Kingdom
Volyn Regional Clinical Hospital ( Site 2816)
🇺🇦Lutsk, Volynska Oblast, Ukraine