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A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)

Primary Purpose

Chronic Cough

Status
Completed
Phase
Phase 3
Locations
Japan
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

Eligibility Criteria

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

Inclusion Criteria:

  • Chest radiograph or computed tomography scan of the thorax 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 sub-investigator.
  • Chronic cough for ≥ 4 months and a diagnosis of refractory or unexplained chronic cough.
  • Persistent cough, despite treatment in accordance with the latest guideline of cough from the Japanese Respiratory Society, cough is a burden to the participant, and needs further treatment.
  • If female, is not pregnant, not breast-feeding, and either is not a woman of childbearing potential or agrees to follow the contraceptive guidance.

Exclusion Criteria:

  • Current smoker, or has given up smoking within 12 months of Screening.
  • History of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status.
  • Has a history of chronic bronchitis.
  • Current use of an angiotensin converting enzyme inhibitor (ACEI) or has taken an ACEI within 3 months of Screening.
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 OR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Visit 1 with unstable renal function (defined as a ≥50% increase of serum creatinine compared to a value obtained at least 6 months prior to Visit 1).
  • History of malignancy ≤ 5 years.
  • User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
  • Systolic blood pressure >160 mm Hg or a diastolic blood pressure >90 mm Hg at Screening.
  • History of cutaneous adverse drug reaction to sulfonamide antibiotics or other sulfonamide-containing drugs.
  • Known allergy/sensitivity or contraindication to gefapixant.
  • Donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant.
  • Previously received gefapixant or is currently participating in or has participated in an interventional clinical study.

Sites / Locations

  • Chubu Rosai Hospital ( Site 3839)
  • National Hospital Organization Nagoya Medical Center ( Site 3898)
  • Nagoya City University Hospital ( Site 3899)
  • Fukuoka University Chikushi Hospital ( Site 3886)
  • Oishi Clinic ( Site 3818)
  • National Hospital Organization Fukuokahigashi Medical Center ( Site 3849)
  • Nagata Hospital ( Site 3815)
  • Tohno Chuo Clinic ( Site 3883)
  • National Hospital Organization Shibukawa Medical Center ( Site 3843)
  • Idaimae Minamiyojo Int Clinic ( Site 3903)
  • Terada Clinic Respiratory Medicine & General Practice ( Site 3907)
  • Kinki Central Hospital ( Site 3910)
  • Kobe City Hospital Organization Kobe City Medical Center West Hospital ( Site 3868)
  • National Hospital Organization Mito Medical Center ( Site 3846)
  • National Hospital Organization Ibarakihigashi National Hospital ( Site 3917)
  • JA Toride Medical Center ( Site 3822)
  • National Hospital Organization Kasumigaura Medical Center ( Site 3844)
  • Ishikawa Prefectural Central Hospital ( Site 3915)
  • Japan Community Health care Organization Kanazawa Hospital ( Site 3817)
  • Komatsu Municipal Hospital ( Site 3892)
  • Kamei Internal Medicine and Respiratory Clinic ( Site 3904)
  • Fujisawa City Hospital ( Site 3891)
  • Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 3878)
  • Yokohama City Minato Red Cross Hospital ( Site 3906)
  • Saiseikai Yokohamashi Nanbu Hospital ( Site 3897)
  • Kanagawa Cardiovascular and Respiratory Center ( Site 3908)
  • Matsusaka City Hospital ( Site 3825)
  • Koyama Medical Clinic ( Site 3838)
  • Nagaoka Red Cross Hospital ( Site 3877)
  • National Hospital Organization Minami-Okayama Medical Center ( Site 3901)
  • Kawaguchi Respiratory Clinic ( Site 3890)
  • Kishiwada City Hospital ( Site 3880)
  • Kindai University Hospital ( Site 3871)
  • Sasaki Naika Clinic ( Site 3872)
  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3900)
  • Sugiura Clinic ( Site 3806)
  • National Hospital Organization Matsue Medical Center ( Site 3848)
  • JapanOrganizationOfOccupationalHealthAndSafety HamamatsuRosaiHospital ( Site 3821)
  • Hamamatsu Medical Center ( Site 3866)
  • National Hospital Organization Tenryu Hospital ( Site 3823)
  • Tokyo Medical University Hachioji Medical Center ( Site 3911)
  • National Hospital Organization Tokyo National Hospital ( Site 3909)
  • Kiheibashi Otolaryngology ( Site 3828)
  • Shimonoseki City Hospital ( Site 3902)
  • Akita University Hospital ( Site 3851)
  • Fukui-ken Saiseikai Hospital ( Site 3874)
  • Gifu Prefectural General Medical Center ( Site 3824)
  • Tochigi Takao Clinic ( Site 3833)
  • Nagano Red Cross Hospital ( Site 3859)
  • Saiseikai Niigata Hospital ( Site 3831)
  • Oita Red Cross Hospital ( Site 3837)
  • Yamagata Clinic ( Site 3813)
  • Chibana Clinic ( Site 3809)
  • Ito ENT Clinic ( Site 3816)
  • Nihonbashi Egawa Clinic ( Site 3805)
  • The Fraternity Memorial Hospital ( Site 3873)
  • Showa University Hospital ( Site 3896)
  • Ebisu Clinic Koukokukai Medical Corporation ( Site 3804)
  • Kono Medical Clinic ( Site 3894)
  • Medical Corporation Kouwakai Kouwa Clinic ( Site 3895)
  • Tokyo Metropolitan Geriatric Hospital ( Site 3905)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gefapixant 15 mg BID

Gefapixant 45 mg BID

Arm Description

Participants will receive gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg twice daily (BID) during the study period (52 weeks).

Participants will receive gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the study period (52 weeks).

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinued Study Drug Due to an AE
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Secondary Outcome Measures

Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
The LCQ is a 19-item cough-specific health-related quality of life (HRQoL) questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model.
Change From Baseline in LCQ Total Score
The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model at weeks 4, 8, 12, 24, 38 and 52 of treatment.
Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score
The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at weeks 4, 8, 12, 24, 38 and 52 of treatment.

Full Information

First Posted
October 3, 2018
Last Updated
September 30, 2021
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03696108
Brief Title
A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)
Official Title
A Phase 3, Randomized, Double-blind Clinical Study to Evaluate the Long-term Safety and Efficacy of MK-7264 in Japanese Adult Participants With Refractory or Unexplained Chronic Cough
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 31, 2018 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
October 7, 2020 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the safety of two doses of gefapixant (MK-7264) in Japanese adult participants with refractory or unexplained chronic cough.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gefapixant 15 mg BID
Arm Type
Experimental
Arm Description
Participants will receive gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg twice daily (BID) during the study period (52 weeks).
Arm Title
Gefapixant 45 mg BID
Arm Type
Experimental
Arm Description
Participants will receive gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the study period (52 weeks).
Intervention Type
Drug
Intervention Name(s)
Gefapixant
Other Intervention Name(s)
MK-7264
Intervention Description
Gefapixant 15 mg or 45 mg tablet administered orally BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to gefapixant 15 mg or 45 mg administered orally BID
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced at Least One Adverse Event (AE)
Description
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to 54 Weeks
Title
Number of Participants Who Discontinued Study Drug Due to an AE
Description
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to 52 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Description
The LCQ is a 19-item cough-specific health-related quality of life (HRQoL) questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model.
Time Frame
Baseline, Week 12
Title
Change From Baseline in LCQ Total Score
Description
The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model at weeks 4, 8, 12, 24, 38 and 52 of treatment.
Time Frame
Baseline, up to 52 Weeks
Title
Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score
Description
The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at weeks 4, 8, 12, 24, 38 and 52 of treatment.
Time Frame
Baseline, Up to 52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chest radiograph or computed tomography scan of the thorax 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 sub-investigator. Chronic cough for ≥ 4 months and a diagnosis of refractory or unexplained chronic cough. Persistent cough, despite treatment in accordance with the latest guideline of cough from the Japanese Respiratory Society, cough is a burden to the participant, and needs further treatment. If female, is not pregnant, not breast-feeding, and either is not a woman of childbearing potential or agrees to follow the contraceptive guidance. Exclusion Criteria: Current smoker, or has given up smoking within 12 months of Screening. History of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status. Has a history of chronic bronchitis. Current use of an angiotensin converting enzyme inhibitor (ACEI) or has taken an ACEI within 3 months of Screening. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 OR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Visit 1 with unstable renal function (defined as a ≥50% increase of serum creatinine compared to a value obtained at least 6 months prior to Visit 1). History of malignancy ≤ 5 years. User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. Systolic blood pressure >160 mm Hg or a diastolic blood pressure >90 mm Hg at Screening. History of cutaneous adverse drug reaction to sulfonamide antibiotics or other sulfonamide-containing drugs. Known allergy/sensitivity or contraindication to gefapixant. Donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant. Previously received gefapixant or is currently participating in or has participated in an interventional clinical 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
Chubu Rosai Hospital ( Site 3839)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 3898)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Nagoya City University Hospital ( Site 3899)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital ( Site 3886)
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Oishi Clinic ( Site 3818)
City
Kasuya-gun
State/Province
Fukuoka
ZIP/Postal Code
811-2310
Country
Japan
Facility Name
National Hospital Organization Fukuokahigashi Medical Center ( Site 3849)
City
Koga
State/Province
Fukuoka
ZIP/Postal Code
811-3195
Country
Japan
Facility Name
Nagata Hospital ( Site 3815)
City
Yanagawa
State/Province
Fukuoka
ZIP/Postal Code
832-0059
Country
Japan
Facility Name
Tohno Chuo Clinic ( Site 3883)
City
Mizunami
State/Province
Gifu
ZIP/Postal Code
509-6134
Country
Japan
Facility Name
National Hospital Organization Shibukawa Medical Center ( Site 3843)
City
Shibukawa
State/Province
Gunma
ZIP/Postal Code
377-0280
Country
Japan
Facility Name
Idaimae Minamiyojo Int Clinic ( Site 3903)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Facility Name
Terada Clinic Respiratory Medicine & General Practice ( Site 3907)
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-0849
Country
Japan
Facility Name
Kinki Central Hospital ( Site 3910)
City
Itami
State/Province
Hyogo
ZIP/Postal Code
664-8533
Country
Japan
Facility Name
Kobe City Hospital Organization Kobe City Medical Center West Hospital ( Site 3868)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
653-0013
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center ( Site 3846)
City
Higashiibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
National Hospital Organization Ibarakihigashi National Hospital ( Site 3917)
City
Naka-gun
State/Province
Ibaraki
ZIP/Postal Code
319-1113
Country
Japan
Facility Name
JA Toride Medical Center ( Site 3822)
City
Toride
State/Province
Ibaraki
ZIP/Postal Code
302-0022
Country
Japan
Facility Name
National Hospital Organization Kasumigaura Medical Center ( Site 3844)
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-8585
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital ( Site 3915)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Japan Community Health care Organization Kanazawa Hospital ( Site 3817)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8610
Country
Japan
Facility Name
Komatsu Municipal Hospital ( Site 3892)
City
Komatsu
State/Province
Ishikawa
ZIP/Postal Code
923-8560
Country
Japan
Facility Name
Kamei Internal Medicine and Respiratory Clinic ( Site 3904)
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
761-8073
Country
Japan
Facility Name
Fujisawa City Hospital ( Site 3891)
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
Facility Name
Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 3878)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Yokohama City Minato Red Cross Hospital ( Site 3906)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
Facility Name
Saiseikai Yokohamashi Nanbu Hospital ( Site 3897)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
234-8503
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center ( Site 3908)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Matsusaka City Hospital ( Site 3825)
City
Matsusaka
State/Province
Mie
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Koyama Medical Clinic ( Site 3838)
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-0872
Country
Japan
Facility Name
Nagaoka Red Cross Hospital ( Site 3877)
City
Nagaoka
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
National Hospital Organization Minami-Okayama Medical Center ( Site 3901)
City
Tsukubo-gun
State/Province
Okayama
ZIP/Postal Code
701-0304
Country
Japan
Facility Name
Kawaguchi Respiratory Clinic ( Site 3890)
City
Higashiosaka
State/Province
Osaka
ZIP/Postal Code
577-0843
Country
Japan
Facility Name
Kishiwada City Hospital ( Site 3880)
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-8501
Country
Japan
Facility Name
Kindai University Hospital ( Site 3871)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Sasaki Naika Clinic ( Site 3872)
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8037
Country
Japan
Facility Name
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3900)
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Sugiura Clinic ( Site 3806)
City
Kawaguchi
State/Province
Saitama
ZIP/Postal Code
332-0012
Country
Japan
Facility Name
National Hospital Organization Matsue Medical Center ( Site 3848)
City
Matsue
State/Province
Shimane
ZIP/Postal Code
690-8556
Country
Japan
Facility Name
JapanOrganizationOfOccupationalHealthAndSafety HamamatsuRosaiHospital ( Site 3821)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8525
Country
Japan
Facility Name
Hamamatsu Medical Center ( Site 3866)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
432-8580
Country
Japan
Facility Name
National Hospital Organization Tenryu Hospital ( Site 3823)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
434-8511
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center ( Site 3911)
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
National Hospital Organization Tokyo National Hospital ( Site 3909)
City
Kiyose
State/Province
Tokyo
ZIP/Postal Code
204-8585
Country
Japan
Facility Name
Kiheibashi Otolaryngology ( Site 3828)
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-0044
Country
Japan
Facility Name
Shimonoseki City Hospital ( Site 3902)
City
Shimonoseki
State/Province
Yamaguchi
ZIP/Postal Code
750-8520
Country
Japan
Facility Name
Akita University Hospital ( Site 3851)
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Fukui-ken Saiseikai Hospital ( Site 3874)
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Gifu Prefectural General Medical Center ( Site 3824)
City
Gifu
ZIP/Postal Code
500-8717
Country
Japan
Facility Name
Tochigi Takao Clinic ( Site 3833)
City
Kagoshima
ZIP/Postal Code
890-0073
Country
Japan
Facility Name
Nagano Red Cross Hospital ( Site 3859)
City
Nagano
ZIP/Postal Code
380-8582
Country
Japan
Facility Name
Saiseikai Niigata Hospital ( Site 3831)
City
Niigata
ZIP/Postal Code
950-1104
Country
Japan
Facility Name
Oita Red Cross Hospital ( Site 3837)
City
Oita
ZIP/Postal Code
870-0033
Country
Japan
Facility Name
Yamagata Clinic ( Site 3813)
City
Oita
ZIP/Postal Code
870-0921
Country
Japan
Facility Name
Chibana Clinic ( Site 3809)
City
Okinawa
ZIP/Postal Code
904-2143
Country
Japan
Facility Name
Ito ENT Clinic ( Site 3816)
City
Shizuoka
ZIP/Postal Code
420-0803
Country
Japan
Facility Name
Nihonbashi Egawa Clinic ( Site 3805)
City
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
The Fraternity Memorial Hospital ( Site 3873)
City
Tokyo
ZIP/Postal Code
130-8587
Country
Japan
Facility Name
Showa University Hospital ( Site 3896)
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Ebisu Clinic Koukokukai Medical Corporation ( Site 3804)
City
Tokyo
ZIP/Postal Code
150-0013
Country
Japan
Facility Name
Kono Medical Clinic ( Site 3894)
City
Tokyo
ZIP/Postal Code
157-0072
Country
Japan
Facility Name
Medical Corporation Kouwakai Kouwa Clinic ( Site 3895)
City
Tokyo
ZIP/Postal Code
170-0003
Country
Japan
Facility Name
Tokyo Metropolitan Geriatric Hospital ( Site 3905)
City
Tokyo
ZIP/Postal Code
173-0015
Country
Japan

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
35752582
Citation
Niimi A, Sagara H, Kikuchi M, Arano I, Sato A, Shirakawa M, La Rosa C, Muccino D. A phase 3, randomized, double-blind, clinical study to evaluate the long-term safety and efficacy of gefapixant in Japanese adult participants with refractory or unexplained chronic cough. Allergol Int. 2022 Oct;71(4):498-504. doi: 10.1016/j.alit.2022.05.006. Epub 2022 Jun 23.
Results Reference
derived

Learn more about this trial

A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)

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