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

Chronic Cough Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696108
• Other study ID #: 7264-038
• Secondary ID: MK-7264-03818415
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2018
• Est. completion date: October 7, 2020

Study information

• Verified date: August 2021
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Drug:
• Gefapixant
Gefapixant 15 mg or 45 mg tablet administered orally BID
• Placebo
Placebo matched to gefapixant 15 mg or 45 mg administered orally BID

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 54 Weeks
Primary	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.	Up to 52 Weeks
Secondary	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.	Baseline, Week 12
Secondary	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.	Baseline, up to 52 Weeks
Secondary	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.	Baseline, Up to 52 Weeks