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

NCT04193176 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 7264-042MK-7264-0422019-002321-29
• Study Type: interventional
• Target: 376
• Locations: 12 countries
• Sites: 90

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.

Conditions

Chronic Cough

Keywords

Cough; Urinary Incontinence, Stress; Respiration disorders; Respiratory tract diseases; Signs and symptoms, respiratory; Signs and symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants With Adverse Events

  Up to ~16 weeks

• Percentage of Participants Who Discontinued Study Intervention Due to AEs

  Up to ~14 weeks

Study Arms (2)

Gefapixant

EXPERIMENTAL

Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.

Drug: Gefapixant

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.

Drug: Placebo

Interventions

Gefapixant DRUG

Administered twice daily as an oral tablet of 45 mg

Also known as: MK-7264

Gefapixant

Placebo DRUG

Administered twice daily as a placebo oral tablet matching gefapixant

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (90)

Center for Clinical Trials, LLC ( Site 0021)

Paramount, California, 90723, United States

Location

Health Awareness, Inc. ( Site 0038)

Jupiter, Florida, 33458, United States

Location

Well Pharma Medical Research, Corp. ( Site 0040)

Miami, Florida, 33173, United States

Location

Lenus Research & Medical Group Llc ( Site 0007)

Sweetwater, Florida, 33172, United States

Location

Florida Pulmonary Research Institute, LLC ( Site 0008)

Winter Park, Florida, 32789, United States

Location

Paul A. Shapero, MD ( Site 0037)

Bangor, Maine, 04401, United States

Location

Chesapeake Clinical Research, Inc ( Site 0022)

White Marsh, Maryland, 21162, United States

Location

University of Missouri ENT & Allergy Center ( Site 0010)

Columbia, Missouri, 65201, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0035)

Las Vegas, Nevada, 89119, United States

Location

Albuquerque Clinical Trials ( Site 0019)

Albuquerque, New Mexico, 87102, United States

Location

American Health Research ( Site 0027)

Charlotte, North Carolina, 28277, United States

Location

Clinical Research of Gastonia ( Site 0016)

Gastonia, North Carolina, 28054, United States

Location

PMG Research of Wilmington ( Site 0004)

Wilmington, North Carolina, 28401, United States

Location

Temple University ( Site 0003)

Philadelphia, Pennsylvania, 19140, United States

Location

AAPRI Clinical Research Institute ( Site 0031)

Warwick, Rhode Island, 02886, United States

Location

Diagnostics Research Group ( Site 0013)

San Antonio, Texas, 78229, United States

Location

TPMG Clinical Research ( Site 0025)

Newport News, Virginia, 23606, United States

Location

Tidewater Physician Multispecialty Group, PC ( Site 0028)

Williamsburg, Virginia, 23188, United States

Location

Bellingham Asthma & Allergy ( Site 0006)

Bellingham, Washington, 98225, United States

Location

Centro Medico Dra De Salvo ( Site 0300)

Buenos Aires, C1426ANZ, Argentina

Location

Investigaciones en Patologias Respiratorias ( Site 0302)

San Miguel de Tucumán, T4000IAQ, Argentina

Location

Fundacion Centro de Investigacion Clinica CIC ( Site 0401)

Medellín, Antioquia, 050021, Colombia

Location

Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)

Medellín, Antioquia, 050036, Colombia

Location

Medplus Medicina Prepagada ( Site 0402)

Bogotá, Bogota D.C., 110221, Colombia

Location

Healthy Medical Center S.A.S ( Site 0404)

Zipaquirá, Cundinamarca, 250252, Colombia

Location

Praxis Dr. Wehgartner-Winkler ( Site 0906)

Augsburg, Bavaria, 86150, Germany

Location

Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0900)

Marburg, Hesse, 35037, Germany

Location

Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0905)

Neu-Isenburg, Hesse, 63263, Germany

Location

Pneumologicum im Suedstadtforum ( Site 0908)

Hanover, Lower Saxony, 30173, Germany

Location

Praxis an der Oper ( Site 0912)

Berlin, 10625, Germany

Location

Bethel Soluciones Medicas S.A. ( Site 0506)

Guatemala City, 01010, Guatemala

Location

Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0500)

Guatemala City, 01010, Guatemala

Location

Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)

Guatemala City, 01010, Guatemala

Location

Clinica Medica Especializada en Neumologia ( Site 0502)

Guatemala City, 01011, Guatemala

Location

Private Clinic ( Site 0505)

Guatemala City, 01011, Guatemala

Location

Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503)

Guatemala City, 01015, Guatemala

Location

Carmel Medical Center ( Site 1104)

Haifa, 34362, Israel

Location

Shaare Zedek Medical Center ( Site 1107)

Jerusalem, 9103102, Israel

Location

Hadassah Ein Karem Jerusalem ( Site 1108)

Jerusalem, 9112001, Israel

Location

Rabin Medical Center ( Site 1102)

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center ( Site 1101)

Ramat Gan, 5265601, Israel

Location

Kaplan Medical Center ( Site 1103)

Rehovot, 7610001, Israel

Location

Sourasky Medical Center ( Site 1100)

Tel Aviv, 6423906, Israel

Location

Clinica Ricardo Palma ( Site 0601)

San Isidro, Lima region, 15036, Peru

Location

Asociacion Civil por la Salud ( Site 0602)

Lima, 15046, Peru

Location

Hospital Nacional Arzobispo Loayza ( Site 0607)

Lima, 15082, Peru

Location

Clinica Belen ( Site 0604)

Piura, 20001, Peru

Location

RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1416)

Belgorod, Belgorod Oblast, 308007, Russia

Location

GBUZ Regional Clinical Hospital 3 ( Site 1420)

Chelyabinsk, Chelyabinsk Oblast, 454021, Russia

Location

City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1400)

Kemerovo, Kemerovo Oblast, 650000, Russia

Location

Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1466)

Moscow, Moscow, 115419, Russia

Location

Krasnogorsk City Hospital Number 1 ( Site 1470)

Krasnogorsk, Moscow Oblast, 143403, Russia

Location

City Clinical Hospital of Emergency Care #2 ( Site 1448)

Novosibirsk, Novosibirsk Oblast, 630102, Russia

Location

Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1438)

Omsk, Omsk Oblast, 644050, Russia

Location

Perm Clinical Center of the Federal Medical and Biological Agency ( Site 1450)

Perm, Permskiy Kray, 614109, Russia

Location

Medi Kom ( Site 1456)

Saint Petersburg, Sankt-Peterburg, 195279, Russia

Location

Limited Liability Company Kurator ( Site 1424)

Saint Petersburg, Sankt-Peterburg, 196240, Russia

Location

SEIHPE Saint Petersburg SMU ( Site 1434)

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1452)

Saratov, Saratov Oblast, 410012, Russia

Location

Family Clinic ( Site 1464)

Yekaterinburg, Sverdlovsk Oblast, 620109, Russia

Location

State health Agency Ulyanovsk regional clinical hospital ( Site 1414)

Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

Location

Voronezh Regional Clinical Hospital #1 ( Site 1440)

Voronezh, Voronezskaja Oblast, 394066, Russia

Location

SBCIH of the Yaroslavl region Central city hospital ( Site 1428)

Yaroslavl, Yaroslavl Oblast, 150040, Russia

Location

Jeonbuk National University Hospital ( Site 1507)

Jeonju, Jeonrabugdo, 54907, South Korea

Location

Wonju Severance Christian Hospital ( Site 1502)

Wŏnju, Kang-won-do, 26426, South Korea

Location

The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1506)

Seoul, 03312, South Korea

Location

Konkuk University Medical Center ( Site 1504)

Seoul, 05030, South Korea

Location

Asan Medical Center ( Site 1505)

Seoul, 05505, South Korea

Location

Hospital Parc Tauli ( Site 1806)

Sabadell, Barcelona, 08208, Spain

Location

Hospital Clinic i Provincial de Barcelona ( Site 1804)

Barcelona, Catalonia, 08036, Spain

Location

Hospital Clinico Universitario de Santiago ( Site 1805)

Santiago de Compostela, La Coruna, 15706, Spain

Location

Hospital General Universitario Gregorio Maranon ( Site 1808)

Madrid, Madrid, Comunidad de, 28007, Spain

Location

F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)

Kyiv, Kyivska Oblast, 03038, Ukraine

Location

F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2819)

Kyiv, Kyivska Oblast, 03038, Ukraine

Location

SE Road Clinical Hospital 2 of Kyiv station ( Site 2812)

Kyiv, Kyivska Oblast, 03049, Ukraine

Location

SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817)

Kyiv, Kyivska Oblast, 03057, Ukraine

Location

Odesa regional clinical hospital ( Site 2804)

Odesa, Odesa Oblast, 65025, Ukraine

Location

City Polyclinic N20 ( Site 2806)

Odesa, Odesa Oblast, 65114, Ukraine

Location

Municipal enterprise "1st City clinical hospital of Poltava -Internal medicine department ( Site 281

Poltava, Poltava Oblast, 36039, Ukraine

Location

Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)

Vinnytsia, Vinnytsia Oblast, 21001, Ukraine

Location

Volyn Regional Clinical Hospital ( Site 2816)

Lutsk, Volyn Oblast, 43005, Ukraine

Location

Medical Center of LLC Medical Clinic Blahomed ( Site 2815)

Kyiv, 01023, Ukraine

Location

GP Direct ( Site 2714)

Harrow, England, HA2 0RQ, United Kingdom

Location

West Walk Surgery ( Site 2700)

Yate, Gloucestershire, BS37 4AX, United Kingdom

Location

Medinova Lakeside Dedicated Research Centre ( Site 2712)

Corby, Northamptonshire, NN18 9EZ, United Kingdom

Location

Kings College Hospital NHS Foundation Trust ( Site 2702)

London, Southwark, SE5 9RS, United Kingdom

Location

Accellacare South London Quality Research Centre ( Site 2706)

Orpington, Surrey, BR5 3QG, United Kingdom

Location

Wokingham Medical Centre ( Site 2708)

Wokingham, West Berkshire, RG40 1XS, United Kingdom

Location

Medinova North London Dedicated Research Centre ( Site 2705)

Northwood, Worcestershire, HA6 2RN, United Kingdom

Location

Medinova Warwickshire Dedicated Research Centre ( Site 2715)

Coventry, CV3 4FJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39222649 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Chronic Cough; Cough; Urinary Incontinence, Stress; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Interventions

Gefapixant

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 10, 2019
• Study Start: May 10, 2020
• Primary Completion: August 18, 2022
• Study Completion: September 2, 2022
• Last Updated: November 5, 2024
• Results First Posted: September 22, 2023

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (5); ES (4); GU (6); PE (4); RU (16); GB (8); CO (4); KR (5); AR (2); UA (10); IL (7); US (19)