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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04193176
Collaborator
(none)
376
Enrollment
90
Locations
2
Arms
28.1
Anticipated Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
376 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 10, 2020
Actual Primary Completion Date :
Aug 18, 2022
Anticipated Study Completion Date :
Sep 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gefapixant

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

Drug: Gefapixant
Administered twice daily as an oral tablet of 45 mg
Other Names:
  • MK-7264

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebo
    Administered twice daily as a placebo oral tablet matching gefapixant

    Outcome Measures

    Primary Outcome Measures

    1. Percent change from baseline in average daily cough-induced stress urinary incontinence (SUI) episodes at Week 12 [Baseline, Week 12]

      Cough-induced SUI episodes will be assessed using an event-driven electronic Incontinence Diary where the participant will record the main cause of each urinary incontinence episode as coughing, another stress reason, or other cause. Episodes of incontinence will be recorded for the week before baseline and treatment visit. Average daily cough induced SUI episodes will be calculated as (sum of daily cough-induced SUI episodes in a week)/number of days recorded. The baseline measure will be defined as the 7-day average daily value immediately prior to initial administration of study intervention. Percentage change in average-daily cough-induced SUI episodes will be calculated as (post baseline minus baseline)/baseline x 100.

    Secondary Outcome Measures

    1. Percentage of participants with one or more adverse events (AEs) [Up to ~Week 14]

      An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs will be calculated.

    2. Percentage of participants who discontinue study drug due to an AE [Up to Week 12]

      An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE will be calculated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Clinical Trials, LLC ( Site 0021) Paramount California United States 90723
    2 Health Awareness, Inc. ( Site 0038) Jupiter Florida United States 33458
    3 Well Pharma Medical Research, Corp. ( Site 0040) Miami Florida United States 33173
    4 Lenus Research & Medical Group Llc ( Site 0007) Sweetwater Florida United States 33172
    5 Florida Pulmonary Research Institute, LLC ( Site 0008) Winter Park Florida United States 32789
    6 Paul A. Shapero, MD ( Site 0037) Bangor Maine United States 04401
    7 Chesapeake Clinical Research, Inc ( Site 0022) White Marsh Maryland United States 21162
    8 University of Missouri ENT & Allergy Center ( Site 0010) Columbia Missouri United States 65201
    9 Alliance for Multispecialty Research, LLC ( Site 0035) Las Vegas Nevada United States 89119
    10 Albuquerque Clinical Trials ( Site 0019) Albuquerque New Mexico United States 87102
    11 American Health Research ( Site 0027) Charlotte North Carolina United States 28277
    12 Clinical Research of Gastonia ( Site 0016) Gastonia North Carolina United States 28054
    13 PMG Research of Wilmington ( Site 0004) Wilmington North Carolina United States 28401
    14 Temple University ( Site 0003) Philadelphia Pennsylvania United States 19140
    15 AAPRI Clinical Research Institute ( Site 0031) Warwick Rhode Island United States 02886
    16 Diagnostics Research Group ( Site 0013) San Antonio Texas United States 78229
    17 TPMG Clinical Research ( Site 0025) Newport News Virginia United States 23606
    18 Tidewater Physician Multispecialty Group, PC ( Site 0028) Williamsburg Virginia United States 23188
    19 Bellingham Asthma & Allergy ( Site 0006) Bellingham Washington United States 98225
    20 Centro Medico Dra De Salvo ( Site 0300) Buenos Aires Argentina C1426ANZ
    21 Investigaciones en Patologias Respiratorias ( Site 0302) Tucuman Argentina T4000IAQ
    22 Fundacion Centro de Investigacion Clinica CIC ( Site 0401) Medellin Antioquia Colombia 050021
    23 Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408) Medellin Antioquia Colombia 050036
    24 Healthy Medical Center S.A.S ( Site 0404) Zipaquira Cundinamarca Colombia 250252
    25 Medplus Medicina Prepagada ( Site 0402) Bogota Distrito Capital De Bogota Colombia 110221
    26 Praxis Dr. Wehgartner-Winkler ( Site 0906) Augsburg Bayern Germany 86150
    27 Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0900) Marburg Hessen Germany 35037
    28 Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0905) Neu-Isenburg Hessen Germany 63263
    29 Pneumologicum im Suedstadtforum ( Site 0908) Hannover Niedersachsen Germany 30173
    30 Praxis an der Oper ( Site 0912) Berlin Germany 10625
    31 Bethel Soluciones Medicas S.A. ( Site 0506) Guatemala Guatemala 01010
    32 Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0500) Guatemala Guatemala 01010
    33 Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504) Guatemala Guatemala 01010
    34 Clinica Medica Especializada en Neumologia ( Site 0502) Guatemala Guatemala 01011
    35 Private Clinic ( Site 0505) Guatemala Guatemala 01011
    36 Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503) Guatemala Guatemala 01015
    37 Carmel Medical Center ( Site 1104) Haifa Israel 34362
    38 Shaare Zedek Medical Center ( Site 1107) Jerusalem Israel 9103102
    39 Hadassah Ein Karem Jerusalem ( Site 1108) Jerusalem Israel 9112001
    40 Rabin Medical Center ( Site 1102) Petah Tikva Israel 4941492
    41 Chaim Sheba Medical Center ( Site 1101) Ramat Gan Israel 5265601
    42 Kaplan Medical Center ( Site 1103) Rehovot Israel 7610001
    43 Sourasky Medical Center ( Site 1100) Tel-Aviv Israel 6423906
    44 Jeonbuk National University Hospital ( Site 1507) Jeonju-si Jeonrabugdo Korea, Republic of 54907
    45 Wonju Severance Christian Hospital ( Site 1502) Wonju-si Kang-won-do Korea, Republic of 26426
    46 The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1506) Seoul Korea, Republic of 03312
    47 Konkuk University Medical Center ( Site 1504) Seoul Korea, Republic of 05030
    48 Asan Medical Center ( Site 1505) Seoul Korea, Republic of 05505
    49 Clinica Ricardo Palma ( Site 0601) San Isidro Lima Peru 15036
    50 Asociacion Civil por la Salud ( Site 0602) Lima Peru 15046
    51 Hospital Nacional Arzobispo Loayza ( Site 0607) Lima Peru 15082
    52 Clinica Belen ( Site 0604) Piura Peru 20001
    53 RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1416) Belgorod Belgorodskaya Oblast Russian Federation 308007
    54 GBUZ Regional Clinical Hospital 3 ( Site 1420) Chelyabinsk Chelyabinskaya Oblast Russian Federation 454021
    55 City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1400) Kemerovo Kemerovskaya Oblast Russian Federation 650000
    56 Krasnogorsk City Hospital Number 1 ( Site 1470) Krasnogorsk Moskovskaya Oblast Russian Federation 143403
    57 Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1466) Moscow Moskva Russian Federation 115419
    58 City Clinical Hospital of Emergency Care #2 ( Site 1448) Novosibirsk Novosibirskaya Oblast Russian Federation 630102
    59 Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1438) Omsk Omskaya Oblast Russian Federation 644050
    60 Perm Clinical Center of the Federal Medical and Biological Agency ( Site 1450) Perm Permskiy Kray Russian Federation 614109
    61 Medi Kom ( Site 1456) Saint Petersburg Sankt-Peterburg Russian Federation 195279
    62 SEIHPE Saint Petersburg SMU ( Site 1434) Saint Petersburg Sankt-Peterburg Russian Federation 197022
    63 Limited Liability Company Kurator ( Site 1424) St. Petersburg Sankt-Peterburg Russian Federation 196240
    64 Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1452) Saratov Saratovskaya Oblast Russian Federation 410012
    65 Family Clinic ( Site 1464) Yekaterinburg Sverdlovskaya Oblast Russian Federation 620109
    66 State health Agency Ulyanovsk regional clinical hospital ( Site 1414) Ulyanovsk Ul Yanovskaya Oblast Russian Federation 432063
    67 Voronezh Regional Clinical Hospital #1 ( Site 1440) Voronezh Voronezskaja Oblast Russian Federation 394066
    68 SBCIH of the Yaroslavl region Central city hospital ( Site 1428) Yaroslavl Yaroslavskaya Oblast Russian Federation 150040
    69 Hospital Parc Tauli ( Site 1806) Sabadell Barcelona Spain 08208
    70 Hospital Clinic i Provincial de Barcelona ( Site 1804) Barcelona Cataluna Spain 08036
    71 Hospital Clinico Universitario de Santiago ( Site 1805) Santiago de Compostela La Coruna Spain 15706
    72 Hospital General Universitario Gregorio Maranon ( Site 1808) Madrid Madrid, Comunidad De Spain 28007
    73 F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808) Kyiv Kyivska Oblast Ukraine 03038
    74 F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2819) Kyiv Kyivska Oblast Ukraine 03038
    75 SE Road Clinical Hospital 2 of Kyiv station ( Site 2812) Kyiv Kyivska Oblast Ukraine 03049
    76 SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817) Kyiv Kyivska Oblast Ukraine 03057
    77 Odesa regional clinical hospital ( Site 2804) Odesa Odeska Oblast Ukraine 65025
    78 City Polyclinic N20 ( Site 2806) Odesa Odeska Oblast Ukraine 65114
    79 Municipal enterprise "1st City clinical hospital of Poltava -Internal medicine department ( Site 281 Poltava Poltavska Oblast Ukraine 36039
    80 Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809) Vinnytsya Vinnytska Oblast Ukraine 21001
    81 Volyn Regional Clinical Hospital ( Site 2816) Lutsk Volynska Oblast Ukraine 43005
    82 Medical Center of LLC Medical Clinic Blahomed ( Site 2815) Kyiv Ukraine 01023
    83 GP Direct ( Site 2714) Harrow England United Kingdom HA2 0RQ
    84 West Walk Surgery ( Site 2700) Yate Gloucestershire United Kingdom BS37 4AX
    85 Medinova Lakeside Dedicated Research Centre ( Site 2712) Corby Northamptonshire United Kingdom NN18 9EZ
    86 Kings College Hospital NHS Foundation Trust ( Site 2702) London Southwark United Kingdom SE5 9RS
    87 Accellacare South London Quality Research Centre ( Site 2706) Orpington Surrey United Kingdom BR5 3QG
    88 Wokingham Medical Centre ( Site 2708) Wokingham West Berkshire United Kingdom RG40 1XS
    89 Medinova North London Dedicated Research Centre ( Site 2705) Northwood Worcestershire United Kingdom HA6 2RN
    90 Medinova Warwickshire Dedicated Research Centre ( Site 2715) Coventry United Kingdom CV3 4FJ

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT04193176
    Other Study ID Numbers:
    • 7264-042
    • MK-7264-042
    • 2019-002321-29
    First Posted:
    Dec 10, 2019
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merck Sharp & Dohme LLC
    Cough
    Urinary Incontinence, Stress
    Respiration disorders
    Respiratory tract diseases
    Signs and symptoms, respiratory
    Signs and symptoms
    Additional relevant MeSH terms:
    Cough
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Aug 25, 2022