Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)

May 11, 2023 updated by: Merck Sharp & Dohme LLC

A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough

The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration >8 weeks after onset of cough symptoms) for <12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

419

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1N 4V3
        • Diex Recherche Quebec Inc ( Site 0805)
      • Quebec, Canada, G1V 4W2
        • Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0800)
    • Quebec
      • Montreal, Quebec, Canada, H1M 1B1
        • Recherche GCP Research ( Site 0802)
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050021
        • Fundacion Centro de Investigacion Clinica CIC ( Site 0401)
      • Medellin, Antioquia, Colombia, 050036
        • Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)
    • Cundinamarca
      • Zipaquira, Cundinamarca, Colombia, 250252
        • Healthy Medical Center S.A.S ( Site 0404)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 110221
        • MedPlus Medicina Prepagada S.A. ( Site 0402)
      • Bogota, Distrito Capital De Bogota, Colombia, 111831
        • Centro Especializado en Enfermedades Pulmonares. ( Site 0410)
    • Santander
      • Floridablanca, Santander, Colombia, 681004
        • Instituto Neumologico del Oriente ( Site 0403)
  • Germany
      • Berlin, Germany, 10969
        • Pneumologisches Studienzentrum ( Site 0911)
    • Hessen
      • Marburg, Hessen, Germany, 35037
        • Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910)
      • Neu-Isenburg, Hessen, Germany, 63263
        • Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0917)
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30173
        • Pneumologicum im Suedstadtforum ( Site 0916)
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)
      • Guatemala, Guatemala, 01011
        • Clinica Medica Especializada en Neumologia ( Site 0502)
      • Guatemala, Guatemala, 01011
        • Private Clinic ( Site 0505)
      • Guatemala, Guatemala, 01015
        • Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503)
      • Guatemala, Guatemala, 01010
        • Celan SA ( Site 0500)
      • Guatemala, Guatemala, 01015
        • Instituto De Alergias y Enfermedades Respiratorias ( Site 0501)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center ( Site 1504)
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 1501)
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System ( Site 1503)
    • Kang-won-do
      • Wonju-si, Kang-won-do, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital ( Site 1502)
    • Seoul
      • Songpagu, Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 1505)
  • Peru
      • Lima, Peru, 15046
        • Asociacion Civil por la Salud ( Site 0602)
      • Lima, Peru, 15082
        • Hospital Nacional Arzobispo Loayza ( Site 0607)
      • Piura, Peru, 20001
        • Clinica Belen ( Site 0604)
    • Lima
      • San Isidro, Lima, Peru, 15036
        • Clinica Ricardo Palma ( Site 0601)
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Centrum Medyczne Pratia Bydgoszcz ( Site 1206)
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-552
        • NZOZ CENTRUM ALERGOLOGII ( Site 1207)
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-033
        • Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1203)
    • Mazowieckie
      • Sochaczew, Mazowieckie, Poland, 96-500
        • RCMed ( Site 1202)
      • Warsaw, Mazowieckie, Poland, 02-777
        • Centrum Medyczne Puławska ( Site 1215)
    • Opolskie
      • Zawadzkie, Opolskie, Poland, 47-120
        • Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1200)
    • Slaskie
      • Katowice, Slaskie, Poland, 40-081
        • Centrum Medyczne Pratia Katowice ( Site 1205)
      • Katowice, Slaskie, Poland, 40-282
        • Centrum Medyczne Silmedic Sp z o o ( Site 1204)
      • Katowice, Slaskie, Poland, 40-851
        • Gyncentrum Clinic Sp. z o.o. ( Site 1208)
  • Russian Federation
    • Belgorodskaya Oblast
      • Belgorod, Belgorodskaya Oblast, Russian Federation, 308007
        • RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1417)
    • Chelyabinskaya Oblast
      • Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454021
        • GBUZ Regional Clinical Hospital 3 ( Site 1421)
    • Kemerovskaya Oblast
      • Kemerovo, Kemerovskaya Oblast, Russian Federation, 650000
        • City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1401)
    • Moskva
      • Moscow, Moskva, Russian Federation, 115280
        • Moscow City Clinical Hospital Number 13 ( Site 1460)
      • Moscow, Moskva, Russian Federation, 115419
        • Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1467)
    • Omskaya Oblast
      • Omsk, Omskaya Oblast, Russian Federation, 644050
        • Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1439)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 194354
        • SPb SBHI City Consultative Diagnostic Center 1 ( Site 1409)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 195271
        • GBUZ LO Center of Occupational Pathology ( Site 1447)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197022
        • SEIHPE Saint Petersburg SMU ( Site 1435)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 198260
        • advisory diagnostic center No.85 ( Site 1455)
      • St. Petersburg, Sankt-Peterburg, Russian Federation, 196240
        • Limited Liability Company Kurator ( Site 1425)
    • Saratovskaya Oblast
      • Saratov, Saratovskaya Oblast, Russian Federation, 410012
        • Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1453)
    • Sverdlovskaya Oblast
      • Yekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620109
        • Family Clinic ( Site 1465)
    • Ul Yanovskaya Oblast
      • Ulyanovsk, Ul Yanovskaya Oblast, Russian Federation, 432063
        • State health Agency Ulyanovsk regional clinical hospital ( Site 1415)
    • Voronezskaja Oblast
      • Voronezh, Voronezskaja Oblast, Russian Federation, 394066
        • Voronezh Regional Clinical Hospital #1 ( Site 1441)
    • Yaroslavskaya Oblast
      • Yaroslavl, Yaroslavskaya Oblast, Russian Federation, 150040
        • SBCIH of the Yaroslavl region Central city hospital ( Site 1429)
  • Spain
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal ( Site 1815)
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos ( Site 1822)
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Parc Tauli ( Site 1821)
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • Hospital Clinico Universitario de Santiago ( Site 1820)
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28007
        • Hospital General Universitario Gregorio Maranon ( Site 1823)
  • Ukraine
      • Kyiv, Ukraine, 01023
        • Medical Center of LLC Medical Clinic Blahomed ( Site 2815)
    • Khersonska Oblast
      • Kherson, Khersonska Oblast, Ukraine, 73000
        • Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2811)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03038
        • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)
      • Kyiv, Kyivska Oblast, Ukraine, 03049
        • SE Road Clinical Hospital 2 of Kyiv station ( Site 2812)
      • Kyiv, Kyivska Oblast, Ukraine, 03057
        • SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817)
      • Kyiv, Kyivska Oblast, Ukraine, 03038
        • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2802)
    • Odeska Oblast
      • Odesa, Odeska Oblast, Ukraine, 65025
        • Odesa regional clinical hospital ( Site 2804)
      • Odesa, Odeska Oblast, Ukraine, 65114
        • City Polyclinic N20 ( Site 2806)
    • Poltavska Oblast
      • Poltava, Poltavska Oblast, Ukraine, 36039
        • Poltava City Clinical Hospital -1 ( Site 2813)
    • Vinnytska Oblast
      • Vinnytsia, Vinnytska Oblast, Ukraine, 21018
        • Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2814)
      • Vinnytsya, Vinnytska Oblast, Ukraine, 21001
        • Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)
    • Volynska Oblast
      • Lutsk, Volynska Oblast, Ukraine, 43005
        • Volyn Regional Clinical Hospital ( Site 2816)
    • Zaporizka Oblast
      • Zaporizhzhia, Zaporizka Oblast, Ukraine, 69096
        • MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2803)
    • Zhytomyrska Oblast
      • Zhytomyr, Zhytomyrska Oblast, Ukraine, 10002
        • Zhytomyr Central City Hospital No. 1 ( Site 2807)
  • United Kingdom
      • Northwood, United Kingdom, HA6 2RN
        • Medinova North London Dedicated Research Centre ( Site 2705)
    • Bradford
      • Shipley, Bradford, United Kingdom, BD18 3SA
        • MeDiNova Yorkshire Dedicated Research Centre ( Site 2715)
    • Gloucestershire
      • Yate, Gloucestershire, United Kingdom, BS37 4AX
        • West Walk Surgery ( Site 2700)
    • Kent
      • Orpington, Kent, United Kingdom, BR5 3QG
        • Medinova South London Research Centre ( Site 2706)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Pulmonary Associates, PA ( Site 0016)
    • California
      • Paramount, California, United States, 90723
        • Center for Clinical Trials, LLC ( Site 0035)
    • Illinois
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic, LLP ( Site 0018)
    • Maryland
      • White Marsh, Maryland, United States, 21162
        • Chesapeake Clinical Research, Inc ( Site 0037)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials ( Site 0030)
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Einstein Center ( Site 0022)
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • American Health Research ( Site 0047)
    • Oregon
      • Medford, Oregon, United States, 97504
        • Clinical Research Institute of Southern Oregon, PC ( Site 0028)
      • Portland, Oregon, United States, 97202
        • Northwest Research Center ( Site 0039)
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • AAPRI Clinical Research Institute ( Site 0051)
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Allergic Disease and Asthma Center ( Site 0027)
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diagnostics Research Group ( Site 0021)
      • Waco, Texas, United States, 76712
        • Allergy & Asthma Center ( Site 0001)
    • Virginia
      • Williamsburg, Virginia, United States, 23188
        • Tidewater Physician Multispecialty Group, PC ( Site 0048)
    • Washington
      • Bellingham, Washington, United States, 98225
        • Bellingham Asthma & Allergy ( Site 0011)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chest radiograph or CT thorax (within 1 year of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease, in the opinion of the principal investigator or the subinvestigator
  • Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for <12 months prior to the screening visit (<14 months after onset of cough symptoms)
  • Has a diagnosis of refractory chronic cough or unexplained chronic cough
  • Female participants are not pregnant, not breastfeeding, not of childbearing potential, or agree 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, defined as cough that produces >1 tablespoon of phlegm, that occurs every day for at least 3 months in a row
  • Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or cervical cancer
  • Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
  • Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide-containing drugs
  • 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
  • Has previously received gefapixant
  • Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Time Frame: Baseline, Week 12
Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12
Time Frame: Baseline, Week 12
Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score is calculated.
Baseline, Week 12
Percentage of Participants With One or More Adverse Events (AEs)
Time Frame: Up to approximately 14 weeks
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 is presented.
Up to approximately 14 weeks
Percentage of Participants Who Discontinue Study Drug Due to an AE
Time Frame: Up to approximately 12 weeks
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 is presented.
Up to approximately 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2020

Primary Completion (Actual)

October 19, 2021

Study Completion (Actual)

November 3, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7264-043
  • MK-7264-043 (Other Identifier: Merck Protocol Number)
  • 2019-002308-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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