Clinical trial NCT04193176: Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Cough
Keywords: Cough
Urinary Incontinence, Stress
Respiration disorders
Respiratory tract diseases
Signs and symptoms, respiratory
Signs and symptoms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 376
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Up to ~16 weeks
measure: Percentage of Participants Who Discontinued Study Intervention Due to AEs
timeFrame: Up to ~14 weeks
Other outcomes:
Locations:
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC ( Site 0021)
state: California
city: Jupiter
country: United States
facility: Health Awareness, Inc. ( Site 0038)
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp. ( Site 0040)
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group Llc ( Site 0007)
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC ( Site 0008)
state: Florida
city: Bangor
country: United States
facility: Paul A. Shapero, MD ( Site 0037)
state: Maine
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc ( Site 0022)
state: Maryland
city: Columbia
country: United States
facility: University of Missouri ENT & Allergy Center ( Site 0010)
state: Missouri
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0035)
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials ( Site 0019)
state: New Mexico
city: Charlotte
country: United States
facility: American Health Research ( Site 0027)
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia ( Site 0016)
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington ( Site 0004)
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University ( Site 0003)
state: Pennsylvania
city: Warwick
country: United States
facility: AAPRI Clinical Research Institute ( Site 0031)
state: Rhode Island
city: San Antonio
country: United States
facility: Diagnostics Research Group ( Site 0013)
state: Texas
city: Newport News
country: United States
facility: TPMG Clinical Research ( Site 0025)
state: Virginia
city: Williamsburg
country: United States
facility: Tidewater Physician Multispecialty Group, PC ( Site 0028)
state: Virginia
city: Bellingham
country: United States
facility: Bellingham Asthma & Allergy ( Site 0006)
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro Medico Dra De Salvo ( Site 0300)
city: Tucuman
country: Argentina
facility: Investigaciones en Patologias Respiratorias ( Site 0302)
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0401)
state: Antioquia
city: Medellin
country: Colombia
facility: Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)
state: Antioquia
city: Zipaquira
country: Colombia
facility: Healthy Medical Center S.A.S ( Site 0404)
state: Cundinamarca
city: Bogota
country: Colombia
facility: Medplus Medicina Prepagada ( Site 0402)
state: Distrito Capital De Bogota
city: Augsburg
country: Germany
facility: Praxis Dr. Wehgartner-Winkler ( Site 0906)
state: Bayern
city: Marburg
country: Germany
facility: Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0900)
state: Hessen
city: Neu-Isenburg
country: Germany
facility: Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0905)
state: Hessen
city: Hannover
country: Germany
facility: Pneumologicum im Suedstadtforum ( Site 0908)
state: Niedersachsen
city: Berlin
country: Germany
facility: Praxis an der Oper ( Site 0912)
city: Guatemala
country: Guatemala
facility: Bethel Soluciones Medicas S.A. ( Site 0506)
city: Guatemala
country: Guatemala
facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0500)
city: Guatemala
country: Guatemala
facility: Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)
city: Guatemala
country: Guatemala
facility: Clinica Medica Especializada en Neumologia ( Site 0502)
city: Guatemala
country: Guatemala
facility: Private Clinic ( Site 0505)
city: Guatemala
country: Guatemala
facility: Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503)
city: Haifa
country: Israel
facility: Carmel Medical Center ( Site 1104)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1107)
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Jerusalem ( Site 1108)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1102)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 1101)
city: Rehovot
country: Israel
facility: Kaplan Medical Center ( Site 1103)
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1100)
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk National University Hospital ( Site 1507)
state: Jeonrabugdo
city: Wonju-si
country: Korea, Republic of
facility: Wonju Severance Christian Hospital ( Site 1502)
state: Kang-won-do
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1506)
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center ( Site 1504)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1505)
city: San Isidro
country: Peru
facility: Clinica Ricardo Palma ( Site 0601)
state: Lima
city: Lima
country: Peru
facility: Asociacion Civil por la Salud ( Site 0602)
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza ( Site 0607)
city: Piura
country: Peru
facility: Clinica Belen ( Site 0604)
city: Belgorod
country: Russian Federation
facility: RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1416)
state: Belgorodskaya Oblast
city: Chelyabinsk
country: Russian Federation
facility: GBUZ Regional Clinical Hospital 3 ( Site 1420)
state: Chelyabinskaya Oblast
city: Kemerovo
country: Russian Federation
facility: City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1400)
state: Kemerovskaya Oblast
city: Krasnogorsk
country: Russian Federation
facility: Krasnogorsk City Hospital Number 1 ( Site 1470)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1466)
state: Moskva
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital of Emergency Care #2 ( Site 1448)
state: Novosibirskaya Oblast
city: Omsk
country: Russian Federation
facility: Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1438)
state: Omskaya Oblast
city: Perm
country: Russian Federation
facility: Perm Clinical Center of the Federal Medical and Biological Agency ( Site 1450)
state: Permskiy Kray
city: Saint Petersburg
country: Russian Federation
facility: Medi Kom ( Site 1456)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: SEIHPE Saint Petersburg SMU ( Site 1434)
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Limited Liability Company Kurator ( Site 1424)
state: Sankt-Peterburg
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1452)
state: Saratovskaya Oblast
city: Yekaterinburg
country: Russian Federation
facility: Family Clinic ( Site 1464)
state: Sverdlovskaya Oblast
city: Ulyanovsk
country: Russian Federation
facility: State health Agency Ulyanovsk regional clinical hospital ( Site 1414)
state: Ul Yanovskaya Oblast
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hospital #1 ( Site 1440)
state: Voronezskaja Oblast
city: Yaroslavl
country: Russian Federation
facility: SBCIH of the Yaroslavl region Central city hospital ( Site 1428)
state: Yaroslavskaya Oblast
city: Sabadell
country: Spain
facility: Hospital Parc Tauli ( Site 1806)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona ( Site 1804)
state: Cataluna
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago ( Site 1805)
state: La Coruna
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 1808)
state: Madrid, Comunidad De
city: Kyiv
country: Ukraine
facility: F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2819)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: SE Road Clinical Hospital 2 of Kyiv station ( Site 2812)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817)
state: Kyivska Oblast
city: Odesa
country: Ukraine
facility: Odesa regional clinical hospital ( Site 2804)
state: Odeska Oblast
city: Odesa
country: Ukraine
facility: City Polyclinic N20 ( Site 2806)
state: Odeska Oblast
city: Poltava
country: Ukraine
facility: Municipal enterprise "1st City clinical hospital of Poltava -Internal medicine department ( Site 281
state: Poltavska Oblast
city: Vinnytsya
country: Ukraine
facility: Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)
state: Vinnytska Oblast
city: Lutsk
country: Ukraine
facility: Volyn Regional Clinical Hospital ( Site 2816)
state: Volynska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Clinic Blahomed ( Site 2815)
city: Harrow
country: United Kingdom
facility: GP Direct ( Site 2714)
state: England
city: Yate
country: United Kingdom
facility: West Walk Surgery ( Site 2700)
state: Gloucestershire
city: Corby
country: United Kingdom
facility: Medinova Lakeside Dedicated Research Centre ( Site 2712)
state: Northamptonshire
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust ( Site 2702)
state: Southwark
city: Orpington
country: United Kingdom
facility: Accellacare South London Quality Research Centre ( Site 2706)
state: Surrey
city: Wokingham
country: United Kingdom
facility: Wokingham Medical Centre ( Site 2708)
state: West Berkshire
city: Northwood
country: United Kingdom
facility: Medinova North London Dedicated Research Centre ( Site 2705)
state: Worcestershire
city: Coventry
country: United Kingdom
facility: Medinova Warwickshire Dedicated Research Centre ( Site 2715)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Birring SS, Cardozo L, Dmochowski R, Dicpinigaitis P, Afzal A, La Rosa C, Lu S, Nguyen AM, Yao R, Reyfman PA. Efficacy and safety of gefapixant in women with chronic cough and cough-induced stress urinary incontinence: a phase 3b, randomised, multicentre, double-blind, placebo-controlled trial. Lancet Respir Med. 2024 Nov;12(11):855-864. doi: 10.1016/S2213-2600(24)00222-4. Epub 2024 Aug 30.