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Chronic CoughPhase 3NCT04193176

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

A Phase 3 study testing Gefapixant in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 90 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Chronic Cough
What is being tested?
Gefapixant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
376 participants
Where
90 sitesin 12 countries
Study dates
10 May 2020to 2 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

90 sites in 12 countries.

90 sites in 12 countries

United States19 sites

  • Albuquerque Clinical Trials ( Site 0019)

    Albuquerque, New Mexico, 87102

  • Paul A. Shapero, MD ( Site 0037)

    Bangor, Maine, 04401

  • Bellingham Asthma & Allergy ( Site 0006)

    Bellingham, Washington, 98225

  • American Health Research ( Site 0027)

    Charlotte, North Carolina, 28277

  • University of Missouri ENT & Allergy Center ( Site 0010)

    Columbia, Missouri, 65201

  • Clinical Research of Gastonia ( Site 0016)

    Gastonia, North Carolina, 28054

  • Health Awareness, Inc. ( Site 0038)

    Jupiter, Florida, 33458

  • Alliance for Multispecialty Research, LLC ( Site 0035)

    Las Vegas, Nevada, 89119

  • Well Pharma Medical Research, Corp. ( Site 0040)

    Miami, Florida, 33173

  • TPMG Clinical Research ( Site 0025)

    Newport News, Virginia, 23606

  • Center for Clinical Trials, LLC ( Site 0021)

    Paramount, California, 90723

  • Temple University ( Site 0003)

    Philadelphia, Pennsylvania, 19140

  • Diagnostics Research Group ( Site 0013)

    San Antonio, Texas, 78229

  • Lenus Research & Medical Group Llc ( Site 0007)

    Sweetwater, Florida, 33172

  • AAPRI Clinical Research Institute ( Site 0031)

    Warwick, Rhode Island, 02886

  • Chesapeake Clinical Research, Inc ( Site 0022)

    White Marsh, Maryland, 21162

  • Tidewater Physician Multispecialty Group, PC ( Site 0028)

    Williamsburg, Virginia, 23188

  • PMG Research of Wilmington ( Site 0004)

    Wilmington, North Carolina, 28401

  • Florida Pulmonary Research Institute, LLC ( Site 0008)

    Winter Park, Florida, 32789

Other trials in United States

Russia16 sites

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

    Belgorod, Belgorod Oblast, 308007

  • GBUZ Regional Clinical Hospital 3 ( Site 1420)

    Chelyabinsk, Chelyabinsk Oblast, 454021

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

    Kemerovo, Kemerovo Oblast, 650000

  • Krasnogorsk City Hospital Number 1 ( Site 1470)

    Krasnogorsk, Moscow Oblast, 143403

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

    Moscow, Moscow, 115419

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

    Novosibirsk, Novosibirsk Oblast, 630102

  • Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1438)

    Omsk, Omsk Oblast, 644050

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

    Perm, Permskiy Kray, 614109

  • Medi Kom ( Site 1456)

    Saint Petersburg, Sankt-Peterburg, 195279

  • Limited Liability Company Kurator ( Site 1424)

    Saint Petersburg, Sankt-Peterburg, 196240

  • SEIHPE Saint Petersburg SMU ( Site 1434)

    Saint Petersburg, Sankt-Peterburg, 197022

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

    Saratov, Saratov Oblast, 410012

  • State health Agency Ulyanovsk regional clinical hospital ( Site 1414)

    Ulyanovsk, Ulyanovsk Oblast, 432063

  • Voronezh Regional Clinical Hospital #1 ( Site 1440)

    Voronezh, Voronezskaja Oblast, 394066

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

    Yaroslavl, Yaroslavl Oblast, 150040

  • Family Clinic ( Site 1464)

    Yekaterinburg, Sverdlovsk Oblast, 620109

Other trials in Russia

Ukraine10 sites

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

    Kyiv, Kyivska Oblast, 03038

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

    Kyiv, Kyivska Oblast, 03038

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

    Kyiv, Kyivska Oblast, 03049

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

    Kyiv, Kyivska Oblast, 03057

  • Medical Center of LLC Medical Clinic Blahomed ( Site 2815)

    Kyiv, 01023

  • Volyn Regional Clinical Hospital ( Site 2816)

    Lutsk, Volyn Oblast, 43005

  • Odesa regional clinical hospital ( Site 2804)

    Odesa, Odesa Oblast, 65025

  • City Polyclinic N20 ( Site 2806)

    Odesa, Odesa Oblast, 65114

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

    Poltava, Poltava Oblast, 36039

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

    Vinnytsia, Vinnytsia Oblast, 21001

Other trials in Ukraine

United Kingdom8 sites

  • Medinova Lakeside Dedicated Research Centre ( Site 2712)

    Corby, Northamptonshire, NN18 9EZ

  • Medinova Warwickshire Dedicated Research Centre ( Site 2715)

    Coventry, CV3 4FJ

  • GP Direct ( Site 2714)

    Harrow, England, HA2 0RQ

  • Kings College Hospital NHS Foundation Trust ( Site 2702)

    London, Southwark, SE5 9RS

  • Medinova North London Dedicated Research Centre ( Site 2705)

    Northwood, Worcestershire, HA6 2RN

  • Accellacare South London Quality Research Centre ( Site 2706)

    Orpington, Surrey, BR5 3QG

  • Wokingham Medical Centre ( Site 2708)

    Wokingham, West Berkshire, RG40 1XS

  • West Walk Surgery ( Site 2700)

    Yate, Gloucestershire, BS37 4AX

Other trials in United Kingdom

Israel7 sites

  • Carmel Medical Center ( Site 1104)

    Haifa, 34362

  • Shaare Zedek Medical Center ( Site 1107)

    Jerusalem, 9103102

  • Hadassah Ein Karem Jerusalem ( Site 1108)

    Jerusalem, 9112001

  • Rabin Medical Center ( Site 1102)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center ( Site 1101)

    Ramat Gan, 5265601

  • Kaplan Medical Center ( Site 1103)

    Rehovot, 7610001

  • Sourasky Medical Center ( Site 1100)

    Tel Aviv, 6423906

Other trials in Israel

Guatemala6 sites

  • Bethel Soluciones Medicas S.A. ( Site 0506)

    Guatemala City, 01010

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

    Guatemala City, 01010

  • Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)

    Guatemala City, 01010

  • Clinica Medica Especializada en Neumologia ( Site 0502)

    Guatemala City, 01011

  • Private Clinic ( Site 0505)

    Guatemala City, 01011

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

    Guatemala City, 01015

Other trials in Guatemala

Germany5 sites

  • Praxis Dr. Wehgartner-Winkler ( Site 0906)

    Augsburg, Bavaria, 86150

  • Praxis an der Oper ( Site 0912)

    Berlin, 10625

  • Pneumologicum im Suedstadtforum ( Site 0908)

    Hanover, Lower Saxony, 30173

  • Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0900)

    Marburg, Hesse, 35037

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

    Neu-Isenburg, Hesse, 63263

Other trials in Germany

South Korea5 sites

  • Jeonbuk National University Hospital ( Site 1507)

    Jeonju, Jeonrabugdo, 54907

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

    Seoul, 03312

  • Konkuk University Medical Center ( Site 1504)

    Seoul, 05030

  • Asan Medical Center ( Site 1505)

    Seoul, 05505

  • Wonju Severance Christian Hospital ( Site 1502)

    Wŏnju, Kang-won-do, 26426

Other trials in South Korea

Colombia4 sites

  • Medplus Medicina Prepagada ( Site 0402)

    Bogotá, Bogota D.C., 110221

  • Fundacion Centro de Investigacion Clinica CIC ( Site 0401)

    Medellín, Antioquia, 050021

  • Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)

    Medellín, Antioquia, 050036

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

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Peru4 sites

  • Asociacion Civil por la Salud ( Site 0602)

    Lima, 15046

  • Hospital Nacional Arzobispo Loayza ( Site 0607)

    Lima, 15082

  • Clinica Belen ( Site 0604)

    Piura, 20001

  • Clinica Ricardo Palma ( Site 0601)

    San Isidro, Lima region, 15036

Other trials in Peru

Spain4 sites

  • Hospital Clinic i Provincial de Barcelona ( Site 1804)

    Barcelona, Catalonia, 08036

  • Hospital General Universitario Gregorio Maranon ( Site 1808)

    Madrid, Madrid, Comunidad de, 28007

  • Hospital Parc Tauli ( Site 1806)

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Santiago ( Site 1805)

    Santiago de Compostela, La Coruna, 15706

Other trials in Spain

Argentina2 sites

  • Centro Medico Dra De Salvo ( Site 0300)

    Buenos Aires, C1426ANZ

  • Investigaciones en Patologias Respiratorias ( Site 0302)

    San Miguel de Tucumán, T4000IAQ

Other trials in Argentina

About this study

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

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
Being tested
Gefapixant, Placebo
Keywords
Cough, Urinary Incontinence, Stress, Respiration disorders, Respiratory tract diseases, Signs and symptoms, respiratory, Signs and symptoms
Medical subject headings
Chronic Cough, Cough, Urinary Incontinence, Stress, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Signs and Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GefapixantDrug

    Also called MK-7264

    Administered twice daily as an oral tablet of 45 mg

  • PlaceboDrug

    Administered twice daily as a placebo oral tablet matching gefapixant

Study groups in NCT04193176
Study groupRoleWhat they receive
GefapixantExperimentalParticipants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Receives: Drug: Gefapixant
PlaceboPlacebo comparatorParticipants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and week 12

Secondary outcomes (2)

  1. 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.

    Measured: Up to ~16 weeks

  2. 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.

    Measured: Up to ~14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start10 May 2020
  3. Primary completion18 Aug 2022
  4. Study completion2 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04193176
Sponsor's protocol ID
7264-042
Other IDs
MK-7264-042, 2019-002321-29, 2019
Status last verified
Oct 2024
First submitted
9 Dec 2019
Last updated
5 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 39222649

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gefapixant in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 90 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Russia, Ukraine, United Kingdom, Israel and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12 (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04193176, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.

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