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

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, Urinary Incontinence, Stress, Respiration disorders, Respiratory tract diseases, Signs and symptoms, respiratory, Signs and symptoms

Eligibility Criteria

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

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

Sites / Locations

  • Center for Clinical Trials, LLC ( Site 0021)
  • Health Awareness, Inc. ( Site 0038)
  • Well Pharma Medical Research, Corp. ( Site 0040)
  • Lenus Research & Medical Group Llc ( Site 0007)
  • Florida Pulmonary Research Institute, LLC ( Site 0008)
  • Paul A. Shapero, MD ( Site 0037)
  • Chesapeake Clinical Research, Inc ( Site 0022)
  • University of Missouri ENT & Allergy Center ( Site 0010)
  • Alliance for Multispecialty Research, LLC ( Site 0035)
  • Albuquerque Clinical Trials ( Site 0019)
  • American Health Research ( Site 0027)
  • Clinical Research of Gastonia ( Site 0016)
  • PMG Research of Wilmington ( Site 0004)
  • Temple University ( Site 0003)
  • AAPRI Clinical Research Institute ( Site 0031)
  • Diagnostics Research Group ( Site 0013)
  • TPMG Clinical Research ( Site 0025)
  • Tidewater Physician Multispecialty Group, PC ( Site 0028)
  • Bellingham Asthma & Allergy ( Site 0006)
  • Centro Medico Dra De Salvo ( Site 0300)
  • Investigaciones en Patologias Respiratorias ( Site 0302)
  • 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 ( Site 0402)
  • Praxis Dr. Wehgartner-Winkler ( Site 0906)
  • Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0900)
  • Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0905)
  • Pneumologicum im Suedstadtforum ( Site 0908)
  • Praxis an der Oper ( Site 0912)
  • Bethel Soluciones Medicas S.A. ( Site 0506)
  • Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( 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)
  • Carmel Medical Center ( Site 1104)
  • Shaare Zedek Medical Center ( Site 1107)
  • Hadassah Ein Karem Jerusalem ( Site 1108)
  • Rabin Medical Center ( Site 1102)
  • Chaim Sheba Medical Center ( Site 1101)
  • Kaplan Medical Center ( Site 1103)
  • Sourasky Medical Center ( Site 1100)
  • Jeonbuk National University Hospital ( Site 1507)
  • Wonju Severance Christian Hospital ( Site 1502)
  • The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1506)
  • Konkuk University Medical Center ( Site 1504)
  • Asan Medical Center ( Site 1505)
  • Clinica Ricardo Palma ( Site 0601)
  • Asociacion Civil por la Salud ( Site 0602)
  • Hospital Nacional Arzobispo Loayza ( Site 0607)
  • Clinica Belen ( Site 0604)
  • RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1416)
  • GBUZ Regional Clinical Hospital 3 ( Site 1420)
  • City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1400)
  • Krasnogorsk City Hospital Number 1 ( Site 1470)
  • Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1466)
  • City Clinical Hospital of Emergency Care #2 ( Site 1448)
  • Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1438)
  • Perm Clinical Center of the Federal Medical and Biological Agency ( Site 1450)
  • Medi Kom ( Site 1456)
  • SEIHPE Saint Petersburg SMU ( Site 1434)
  • Limited Liability Company Kurator ( Site 1424)
  • Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1452)
  • Family Clinic ( Site 1464)
  • State health Agency Ulyanovsk regional clinical hospital ( Site 1414)
  • Voronezh Regional Clinical Hospital #1 ( Site 1440)
  • SBCIH of the Yaroslavl region Central city hospital ( Site 1428)
  • Hospital Parc Tauli ( Site 1806)
  • Hospital Clinic i Provincial de Barcelona ( Site 1804)
  • Hospital Clinico Universitario de Santiago ( Site 1805)
  • Hospital General Universitario Gregorio Maranon ( Site 1808)
  • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)
  • F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2819)
  • 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)
  • Municipal enterprise "1st City clinical hospital of Poltava -Internal medicine department ( Site 281
  • Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)
  • Volyn Regional Clinical Hospital ( Site 2816)
  • Medical Center of LLC Medical Clinic Blahomed ( Site 2815)
  • GP Direct ( Site 2714)
  • West Walk Surgery ( Site 2700)
  • Medinova Lakeside Dedicated Research Centre ( Site 2712)
  • Kings College Hospital NHS Foundation Trust ( Site 2702)
  • Accellacare South London Quality Research Centre ( Site 2706)
  • Wokingham Medical Centre ( Site 2708)
  • Medinova North London Dedicated Research Centre ( Site 2705)
  • Medinova Warwickshire Dedicated Research Centre ( Site 2715)

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

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 9, 2019
Last Updated
August 29, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04193176
Brief Title
Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2020 (Actual)
Primary Completion Date
August 18, 2022 (Actual)
Study Completion Date
September 2, 2022 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough
Keywords
Cough, Urinary Incontinence, Stress, 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
376 (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
Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12
Description
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.
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Description
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.
Time Frame
Up to ~16 weeks
Title
Percentage of Participants Who Discontinued Study Intervention Due to AEs
Description
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.
Time Frame
Up to ~14 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Center for Clinical Trials, LLC ( Site 0021)
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Health Awareness, Inc. ( Site 0038)
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Well Pharma Medical Research, Corp. ( Site 0040)
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Lenus Research & Medical Group Llc ( Site 0007)
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Florida Pulmonary Research Institute, LLC ( Site 0008)
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Paul A. Shapero, MD ( Site 0037)
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Chesapeake Clinical Research, Inc ( Site 0022)
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
University of Missouri ENT & Allergy Center ( Site 0010)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0035)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Albuquerque Clinical Trials ( Site 0019)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
American Health Research ( Site 0027)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Clinical Research of Gastonia ( Site 0016)
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
PMG Research of Wilmington ( Site 0004)
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Temple University ( Site 0003)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
AAPRI Clinical Research Institute ( Site 0031)
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Diagnostics Research Group ( Site 0013)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
TPMG Clinical Research ( Site 0025)
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Tidewater Physician Multispecialty Group, PC ( Site 0028)
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23188
Country
United States
Facility Name
Bellingham Asthma & Allergy ( Site 0006)
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Centro Medico Dra De Salvo ( Site 0300)
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Investigaciones en Patologias Respiratorias ( Site 0302)
City
Tucuman
ZIP/Postal Code
T4000IAQ
Country
Argentina
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 ( Site 0402)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Praxis Dr. Wehgartner-Winkler ( Site 0906)
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86150
Country
Germany
Facility Name
Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0900)
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany
Facility Name
Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0905)
City
Neu-Isenburg
State/Province
Hessen
ZIP/Postal Code
63263
Country
Germany
Facility Name
Pneumologicum im Suedstadtforum ( Site 0908)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30173
Country
Germany
Facility Name
Praxis an der Oper ( Site 0912)
City
Berlin
ZIP/Postal Code
10625
Country
Germany
Facility Name
Bethel Soluciones Medicas S.A. ( Site 0506)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( 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
Carmel Medical Center ( Site 1104)
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Shaare Zedek Medical Center ( Site 1107)
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Ein Karem Jerusalem ( Site 1108)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin Medical Center ( Site 1102)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center ( Site 1101)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Kaplan Medical Center ( Site 1103)
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Sourasky Medical Center ( Site 1100)
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Jeonbuk National University Hospital ( Site 1507)
City
Jeonju-si
State/Province
Jeonrabugdo
ZIP/Postal Code
54907
Country
Korea, Republic of
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
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1506)
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center ( Site 1504)
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 1505)
City
Seoul
ZIP/Postal Code
05505
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
RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1416)
City
Belgorod
State/Province
Belgorodskaya Oblast
ZIP/Postal Code
308007
Country
Russian Federation
Facility Name
GBUZ Regional Clinical Hospital 3 ( Site 1420)
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 1400)
City
Kemerovo
State/Province
Kemerovskaya Oblast
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Krasnogorsk City Hospital Number 1 ( Site 1470)
City
Krasnogorsk
State/Province
Moskovskaya Oblast
ZIP/Postal Code
143403
Country
Russian Federation
Facility Name
Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1466)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
City Clinical Hospital of Emergency Care #2 ( Site 1448)
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630102
Country
Russian Federation
Facility Name
Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1438)
City
Omsk
State/Province
Omskaya Oblast
ZIP/Postal Code
644050
Country
Russian Federation
Facility Name
Perm Clinical Center of the Federal Medical and Biological Agency ( Site 1450)
City
Perm
State/Province
Permskiy Kray
ZIP/Postal Code
614109
Country
Russian Federation
Facility Name
Medi Kom ( Site 1456)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
195279
Country
Russian Federation
Facility Name
SEIHPE Saint Petersburg SMU ( Site 1434)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Limited Liability Company Kurator ( Site 1424)
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 1452)
City
Saratov
State/Province
Saratovskaya Oblast
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Family Clinic ( Site 1464)
City
Yekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
State health Agency Ulyanovsk regional clinical hospital ( Site 1414)
City
Ulyanovsk
State/Province
Ul Yanovskaya Oblast
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Hospital #1 ( Site 1440)
City
Voronezh
State/Province
Voronezskaja Oblast
ZIP/Postal Code
394066
Country
Russian Federation
Facility Name
SBCIH of the Yaroslavl region Central city hospital ( Site 1428)
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
Hospital Parc Tauli ( Site 1806)
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona ( Site 1804)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago ( Site 1805)
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 1808)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28007
Country
Spain
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
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2819)
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
Municipal enterprise "1st City clinical hospital of Poltava -Internal medicine department ( Site 281
City
Poltava
State/Province
Poltavska Oblast
ZIP/Postal Code
36039
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
Medical Center of LLC Medical Clinic Blahomed ( Site 2815)
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
GP Direct ( Site 2714)
City
Harrow
State/Province
England
ZIP/Postal Code
HA2 0RQ
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 Lakeside Dedicated Research Centre ( Site 2712)
City
Corby
State/Province
Northamptonshire
ZIP/Postal Code
NN18 9EZ
Country
United Kingdom
Facility Name
Kings College Hospital NHS Foundation Trust ( Site 2702)
City
London
State/Province
Southwark
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Accellacare South London Quality Research Centre ( Site 2706)
City
Orpington
State/Province
Surrey
ZIP/Postal Code
BR5 3QG
Country
United Kingdom
Facility Name
Wokingham Medical Centre ( Site 2708)
City
Wokingham
State/Province
West Berkshire
ZIP/Postal Code
RG40 1XS
Country
United Kingdom
Facility Name
Medinova North London Dedicated Research Centre ( Site 2705)
City
Northwood
State/Province
Worcestershire
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Medinova Warwickshire Dedicated Research Centre ( Site 2715)
City
Coventry
ZIP/Postal Code
CV3 4FJ
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
Links:
URL
https://www.merckclinicaltrials.com
Description
Merck Clinical Trials Information

Learn more about this trial

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

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