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Efficacy and Safety of Gefapi...

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

NCT ID: NCT04193202

Last Updated: 2023-05-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

419 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2021-11-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gefapixant

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

Group Type EXPERIMENTAL

Gefapixant

Intervention Type DRUG

Administered twice daily as an oral tablet of 45 mg

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered twice daily as a placebo oral tablet matching gefapixant

Interventions

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Gefapixant

Administered twice daily as an oral tablet of 45 mg

Intervention Type DRUG

Placebo

Administered twice daily as a placebo oral tablet matching gefapixant

Intervention Type DRUG

Other Intervention Names

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MK-7264

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Pulmonary Associates, PA ( Site 0016)

Phoenix, Arizona, United States

Site Status

Center for Clinical Trials, LLC ( Site 0035)

Paramount, California, United States

Site Status

Springfield Clinic, LLP ( Site 0018)

Springfield, Illinois, United States

Site Status

Chesapeake Clinical Research, Inc ( Site 0037)

White Marsh, Maryland, United States

Site Status

Albuquerque Clinical Trials ( Site 0030)

Albuquerque, New Mexico, United States

Site Status

Montefiore Einstein Center ( Site 0022)

The Bronx, New York, United States

Site Status

American Health Research ( Site 0047)

Charlotte, North Carolina, United States

Site Status

Clinical Research Institute of Southern Oregon, PC ( Site 0028)

Medford, Oregon, United States

Site Status

Northwest Research Center ( Site 0039)

Portland, Oregon, United States

Site Status

AAPRI Clinical Research Institute ( Site 0051)

Lincoln, Rhode Island, United States

Site Status

Allergic Disease and Asthma Center ( Site 0027)

Greenville, South Carolina, United States

Site Status

Diagnostics Research Group ( Site 0021)

San Antonio, Texas, United States

Site Status

Allergy & Asthma Center ( Site 0001)

Waco, Texas, United States

Site Status

Tidewater Physician Multispecialty Group, PC ( Site 0048)

Williamsburg, Virginia, United States

Site Status

Bellingham Asthma & Allergy ( Site 0011)

Bellingham, Washington, United States

Site Status

Recherche GCP Research ( Site 0802)

Montreal, Quebec, Canada

Site Status

Diex Recherche Quebec Inc ( Site 0805)

Québec, Quebec, Canada

Site Status

Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0800)

Québec, Quebec, Canada

Site Status

Fundacion Centro de Investigacion Clinica CIC ( Site 0401)

Medellín, Antioquia, Colombia

Site Status

Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)

Medellín, Antioquia, Colombia

Site Status

MedPlus Medicina Prepagada S.A. ( Site 0402)

Bogotá, Bogota D.C., Colombia

Site Status

Centro Especializado en Enfermedades Pulmonares. ( Site 0410)

Bogotá, Bogota D.C., Colombia

Site Status

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

Zipaquirá, Cundinamarca, Colombia

Site Status

Instituto Neumologico del Oriente ( Site 0403)

Floridablanca, Santander Department, Colombia

Site Status

Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910)

Marburg, Hesse, Germany

Site Status

Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0917)

Neu-Isenburg, Hesse, Germany

Site Status

Pneumologicum im Suedstadtforum ( Site 0916)

Hanover, Lower Saxony, Germany

Site Status

Pneumologisches Studienzentrum ( Site 0911)

Berlin, , Germany

Site Status

Celan SA ( Site 0500)

Guatemala City, , Guatemala

Site Status

Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)

Guatemala City, , Guatemala

Site Status

Clinica Medica Especializada en Neumologia ( Site 0502)

Guatemala City, , Guatemala

Site Status

Private Clinic ( Site 0505)

Guatemala City, , Guatemala

Site Status

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

Guatemala City, , Guatemala

Site Status

Instituto De Alergias y Enfermedades Respiratorias ( Site 0501)

Guatemala City, , Guatemala

Site Status

Clinica Ricardo Palma ( Site 0601)

San Isidro, Lima region, Peru

Site Status

Asociacion Civil por la Salud ( Site 0602)

Lima, , Peru

Site Status

Hospital Nacional Arzobispo Loayza ( Site 0607)

Lima, , Peru

Site Status

Clinica Belen ( Site 0604)

Piura, , Peru

Site Status

Centrum Medyczne Pratia Bydgoszcz ( Site 1206)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1203)

Krakow, Lesser Poland Voivodeship, Poland

Site Status

NZOZ CENTRUM ALERGOLOGII ( Site 1207)

Lublin, Lublin Voivodeship, Poland

Site Status

RCMed ( Site 1202)

Sochaczew, Masovian Voivodeship, Poland

Site Status

Centrum Medyczne Puławska ( Site 1215)

Warsaw, Masovian Voivodeship, Poland

Site Status

Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1200)

Zawadzkie, Opole Voivodeship, Poland

Site Status

Centrum Medyczne Pratia Katowice ( Site 1205)

Katowice, Silesian Voivodeship, Poland

Site Status

Centrum Medyczne Silmedic Sp z o o ( Site 1204)

Katowice, Silesian Voivodeship, Poland

Site Status

Gyncentrum Clinic Sp. z o.o. ( Site 1208)

Katowice, Silesian Voivodeship, Poland

Site Status

RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1417)

Belgorod, Belgorod Oblast, Russia

Site Status

GBUZ Regional Clinical Hospital 3 ( Site 1421)

Chelyabinsk, Chelyabinsk Oblast, Russia

Site Status

City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1401)

Kemerovo, Kemerovo Oblast, Russia

Site Status

Moscow City Clinical Hospital Number 13 ( Site 1460)

Moscow, Moscow, Russia

Site Status

Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1467)

Moscow, Moscow, Russia

Site Status