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

Chronic Cough Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193176
• Other study ID #: 7264-042
• Secondary ID: MK-7264-0422019-
• Status: Completed
• Phase: Phase 3
• Start date: May 10, 2020
• Est. completion date: September 2, 2022

Study information

• Verified date: August 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: September 2, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Cough
• Cough
• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• Gefapixant
Administered twice daily as an oral tablet of 45 mg
• Placebo
Administered twice daily as a placebo oral tablet matching gefapixant

Locations

Country	Name	City	State
Argentina	Centro Medico Dra De Salvo ( Site 0300)	Buenos Aires
Argentina	Investigaciones en Patologias Respiratorias ( Site 0302)	Tucuman
Colombia	Medplus Medicina Prepagada ( Site 0402)	Bogota	Distrito Capital De Bogota
Colombia	Fundacion Centro de Investigacion Clinica CIC ( Site 0401)	Medellin	Antioquia
Colombia	Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)	Medellin	Antioquia
Colombia	Healthy Medical Center S.A.S ( Site 0404)	Zipaquira	Cundinamarca
Germany	Praxis Dr. Wehgartner-Winkler ( Site 0906)	Augsburg	Bayern
Germany	Praxis an der Oper ( Site 0912)	Berlin
Germany	Pneumologicum im Suedstadtforum ( Site 0908)	Hannover	Niedersachsen
Germany	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
Guatemala	Bethel Soluciones Medicas S.A. ( Site 0506)	Guatemala
Guatemala	Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0500)	Guatemala
Guatemala	Clinica Medica Especializada en Neumologia ( Site 0502)	Guatemala
Guatemala	Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)	Guatemala
Guatemala	Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503)	Guatemala
Guatemala	Private Clinic ( Site 0505)	Guatemala
Israel	Carmel Medical Center ( Site 1104)	Haifa
Israel	Hadassah Ein Karem Jerusalem ( Site 1108)	Jerusalem
Israel	Shaare Zedek Medical Center ( Site 1107)	Jerusalem
Israel	Rabin Medical Center ( Site 1102)	Petah Tikva
Israel	Chaim Sheba Medical Center ( Site 1101)	Ramat Gan
Israel	Kaplan Medical Center ( Site 1103)	Rehovot
Israel	Sourasky Medical Center ( Site 1100)	Tel-Aviv
Korea, Republic of	Jeonbuk National University Hospital ( Site 1507)	Jeonju-si	Jeonrabugdo
Korea, Republic of	Asan Medical Center ( Site 1505)	Seoul
Korea, Republic of	Konkuk University Medical Center ( Site 1504)	Seoul
Korea, Republic of	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
Peru	Asociacion Civil por la Salud ( Site 0602)	Lima
Peru	Hospital Nacional Arzobispo Loayza ( Site 0607)	Lima
Peru	Clinica Belen ( Site 0604)	Piura
Peru	Clinica Ricardo Palma ( Site 0601)	San Isidro	Lima
Russian Federation	RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1416)	Belgorod	Belgorodskaya Oblast
Russian Federation	GBUZ Regional Clinical Hospital 3 ( Site 1420)	Chelyabinsk	Chelyabinskaya Oblast
Russian Federation	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	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	Medi Kom ( Site 1456)	Saint Petersburg	Sankt-Peterburg
Russian Federation	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	Limited Liability Company Kurator ( Site 1424)	St. Petersburg	Sankt-Peterburg
Russian Federation	State health Agency Ulyanovsk regional clinical hospital ( Site 1414)	Ulyanovsk	Ul Yanovskaya Oblast
Russian Federation	Voronezh Regional Clinical Hospital #1 ( Site 1440)	Voronezh	Voronezskaja Oblast
Russian Federation	SBCIH of the Yaroslavl region Central city hospital ( Site 1428)	Yaroslavl	Yaroslavskaya Oblast
Russian Federation	Family Clinic ( Site 1464)	Yekaterinburg	Sverdlovskaya Oblast
Spain	Hospital Clinic i Provincial de Barcelona ( Site 1804)	Barcelona	Cataluna
Spain	Hospital General Universitario Gregorio Maranon ( Site 1808)	Madrid	Madrid, Comunidad De
Spain	Hospital Parc Tauli ( Site 1806)	Sabadell	Barcelona
Spain	Hospital Clinico Universitario de Santiago ( Site 1805)	Santiago de Compostela	La Coruna
Ukraine	F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)	Kyiv	Kyivska Oblast
Ukraine	F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2819)	Kyiv	Kyivska Oblast
Ukraine	Medical Center of LLC Medical Clinic Blahomed ( Site 2815)	Kyiv
Ukraine	SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817)	Kyiv	Kyivska Oblast
Ukraine	SE Road Clinical Hospital 2 of Kyiv station ( Site 2812)	Kyiv	Kyivska Oblast
Ukraine	Volyn Regional Clinical Hospital ( Site 2816)	Lutsk	Volynska Oblast
Ukraine	City Polyclinic N20 ( Site 2806)	Odesa	Odeska Oblast
Ukraine	Odesa regional clinical hospital ( Site 2804)	Odesa	Odeska Oblast
Ukraine	Municipal enterprise "1st City clinical hospital of Poltava -Internal medicine department ( Site 281	Poltava	Poltavska Oblast
Ukraine	Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)	Vinnytsya	Vinnytska Oblast
United Kingdom	Medinova Lakeside Dedicated Research Centre ( Site 2712)	Corby	Northamptonshire
United Kingdom	Medinova Warwickshire Dedicated Research Centre ( Site 2715)	Coventry
United Kingdom	GP Direct ( Site 2714)	Harrow	England
United Kingdom	Kings College Hospital NHS Foundation Trust ( Site 2702)	London	Southwark
United Kingdom	Medinova North London Dedicated Research Centre ( Site 2705)	Northwood	Worcestershire
United Kingdom	Accellacare South London Quality Research Centre ( Site 2706)	Orpington	Surrey
United Kingdom	Wokingham Medical Centre ( Site 2708)	Wokingham	West Berkshire
United Kingdom	West Walk Surgery ( Site 2700)	Yate	Gloucestershire
United States	Albuquerque Clinical Trials ( Site 0019)	Albuquerque	New Mexico
United States	Paul A. Shapero, MD ( Site 0037)	Bangor	Maine
United States	Bellingham Asthma & Allergy ( Site 0006)	Bellingham	Washington
United States	American Health Research ( Site 0027)	Charlotte	North Carolina
United States	University of Missouri ENT & Allergy Center ( Site 0010)	Columbia	Missouri
United States	Clinical Research of Gastonia ( Site 0016)	Gastonia	North Carolina
United States	Health Awareness, Inc. ( Site 0038)	Jupiter	Florida
United States	Alliance for Multispecialty Research, LLC ( Site 0035)	Las Vegas	Nevada
United States	Well Pharma Medical Research, Corp. ( Site 0040)	Miami	Florida
United States	TPMG Clinical Research ( Site 0025)	Newport News	Virginia
United States	Center for Clinical Trials, LLC ( Site 0021)	Paramount	California
United States	Temple University ( Site 0003)	Philadelphia	Pennsylvania
United States	Diagnostics Research Group ( Site 0013)	San Antonio	Texas
United States	Lenus Research & Medical Group Llc ( Site 0007)	Sweetwater	Florida
United States	AAPRI Clinical Research Institute ( Site 0031)	Warwick	Rhode Island
United States	Chesapeake Clinical Research, Inc ( Site 0022)	White Marsh	Maryland
United States	Tidewater Physician Multispecialty Group, PC ( Site 0028)	Williamsburg	Virginia
United States	PMG Research of Wilmington ( Site 0004)	Wilmington	North Carolina
United States	Florida Pulmonary Research Institute, LLC ( Site 0008)	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Colombia,  Germany,  Guatemala,  Israel,  Korea, Republic of,  Peru,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at 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.	Baseline and week 12
Secondary	Percentage of Participants With Adverse Events	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.	Up to ~16 weeks
Secondary	Percentage of Participants Who Discontinued Study Intervention Due to AEs	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.	Up to ~14 weeks

External Links

•   Merck Clinical Trials Information