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

Primary Purpose

Chronic Cough

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gefapixant
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Cough focused on measuring Cough, Respiration disorders, Respiratory tract diseases, Signs and symptoms, respiratory, Signs and symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pulmonary Associates, PA ( Site 0016)
  • Center for Clinical Trials, LLC ( Site 0035)
  • Springfield Clinic, LLP ( Site 0018)
  • Chesapeake Clinical Research, Inc ( Site 0037)
  • Albuquerque Clinical Trials ( Site 0030)
  • Montefiore Einstein Center ( Site 0022)
  • American Health Research ( Site 0047)
  • Clinical Research Institute of Southern Oregon, PC ( Site 0028)
  • Northwest Research Center ( Site 0039)
  • AAPRI Clinical Research Institute ( Site 0051)
  • Allergic Disease and Asthma Center ( Site 0027)
  • Diagnostics Research Group ( Site 0021)
  • Allergy & Asthma Center ( Site 0001)
  • Tidewater Physician Multispecialty Group, PC ( Site 0048)
  • Bellingham Asthma & Allergy ( Site 0011)
  • Recherche GCP Research ( Site 0802)
  • Diex Recherche Quebec Inc ( Site 0805)
  • Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0800)
  • Fundacion Centro de Investigacion Clinica CIC ( Site 0401)
  • Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)
  • Healthy Medical Center S.A.S ( Site 0404)
  • MedPlus Medicina Prepagada S.A. ( Site 0402)
  • Centro Especializado en Enfermedades Pulmonares. ( Site 0410)
  • Instituto Neumologico del Oriente ( Site 0403)
  • Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910)
  • Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0917)
  • Pneumologicum im Suedstadtforum ( Site 0916)
  • Pneumologisches Studienzentrum ( Site 0911)
  • Celan SA ( Site 0500)
  • Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)
  • Clinica Medica Especializada en Neumologia ( Site 0502)
  • Private Clinic ( Site 0505)
  • Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503)
  • Instituto De Alergias y Enfermedades Respiratorias ( Site 0501)
  • Wonju Severance Christian Hospital ( Site 1502)
  • Asan Medical Center ( Site 1505)
  • Seoul National University Hospital ( Site 1501)
  • Severance Hospital Yonsei University Health System ( Site 1503)
  • Konkuk University Medical Center ( Site 1504)
  • Clinica Ricardo Palma ( Site 0601)
  • Asociacion Civil por la Salud ( Site 0602)
  • Hospital Nacional Arzobispo Loayza ( Site 0607)
  • Clinica Belen ( Site 0604)
  • Centrum Medyczne Pratia Bydgoszcz ( Site 1206)
  • NZOZ CENTRUM ALERGOLOGII ( Site 1207)
  • Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1203)
  • RCMed ( Site 1202)
  • Centrum Medyczne Puławska ( Site 1215)
  • Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1200)
  • Centrum Medyczne Pratia Katowice ( Site 1205)
  • Centrum Medyczne Silmedic Sp z o o ( Site 1204)
  • Gyncentrum Clinic Sp. z o.o. ( Site 1208)
  • RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1417)
  • GBUZ Regional Clinical Hospital 3 ( Site 1421)
  • City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1401)
  • Moscow City Clinical Hospital Number 13 ( Site 1460)
  • Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1467)
  • Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1439)
  • SPb SBHI City Consultative Diagnostic Center 1 ( Site 1409)
  • GBUZ LO Center of Occupational Pathology ( Site 1447)
  • SEIHPE Saint Petersburg SMU ( Site 1435)
  • advisory diagnostic center No.85 ( Site 1455)
  • Limited Liability Company Kurator ( Site 1425)
  • Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1453)
  • Family Clinic ( Site 1465)
  • State health Agency Ulyanovsk regional clinical hospital ( Site 1415)
  • Voronezh Regional Clinical Hospital #1 ( Site 1441)
  • SBCIH of the Yaroslavl region Central city hospital ( Site 1429)
  • Hospital Parc Tauli ( Site 1821)
  • Hospital Clinico Universitario de Santiago ( Site 1820)
  • Hospital General Universitario Gregorio Maranon ( Site 1823)
  • Hospital Ramon y Cajal ( Site 1815)
  • Hospital Clinico San Carlos ( Site 1822)
  • Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2811)
  • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2802)
  • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)
  • SE Road Clinical Hospital 2 of Kyiv station ( Site 2812)
  • SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817)
  • Odesa regional clinical hospital ( Site 2804)
  • City Polyclinic N20 ( Site 2806)
  • Poltava City Clinical Hospital -1 ( Site 2813)
  • Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2814)
  • Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)
  • Volyn Regional Clinical Hospital ( Site 2816)
  • MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2803)
  • Zhytomyr Central City Hospital No. 1 ( Site 2807)
  • Medical Center of LLC Medical Clinic Blahomed ( Site 2815)
  • MeDiNova Yorkshire Dedicated Research Centre ( Site 2715)
  • West Walk Surgery ( Site 2700)
  • Medinova South London Research Centre ( Site 2706)
  • Medinova North London Dedicated Research Centre ( Site 2705)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gefapixant

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at 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.

Secondary Outcome Measures

Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at 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.
Percentage of Participants With One or More Adverse Events (AEs)
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.
Percentage of Participants Who Discontinue Study Drug Due to an AE
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.

Full Information

First Posted
December 9, 2019
Last Updated
May 11, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04193202
Brief Title
Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
October 19, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough
Keywords
Cough, Respiration disorders, Respiratory tract diseases, Signs and symptoms, respiratory, Signs and symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gefapixant
Arm Type
Experimental
Arm Description
Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Gefapixant
Other Intervention Name(s)
MK-7264
Intervention Description
Administered twice daily as an oral tablet of 45 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered twice daily as a placebo oral tablet matching gefapixant
Primary Outcome Measure Information:
Title
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Percentage of Participants With One or More Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 14 weeks
Title
Percentage of Participants Who Discontinue Study Drug Due to an AE
Description
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.
Time Frame
Up to approximately 12 weeks

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
36879087
Citation
McGarvey L, Sher M, Shvarts YG, Lu S, Wu WC, Xu P, Schelfhout J, La Rosa C, Nguyen AM, Reyfman PA, Afzal AS. The Efficacy and Safety of Gefapixant in a Phase 3b Trial of Patients with Recent-Onset Chronic Cough. Lung. 2023 Apr;201(2):111-118. doi: 10.1007/s00408-023-00606-w. Epub 2023 Mar 6.
Results Reference
result

Learn more about this trial

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

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