Clinical trial NCT03696108: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Cough
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-10-04
Enrollment: 175
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: Up to 54 Weeks
measure: Number of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to 52 Weeks
Secondary outcomes:
measure: Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in LCQ Total Score
timeFrame: Baseline, up to 52 Weeks
measure: Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score
timeFrame: Baseline, Up to 52 Weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Chubu Rosai Hospital ( Site 3839)
state: Aichi
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center ( Site 3898)
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital ( Site 3899)
state: Aichi
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital ( Site 3886)
state: Fukuoka
city: Kasuya-gun
country: Japan
facility: Oishi Clinic ( Site 3818)
state: Fukuoka
city: Koga
country: Japan
facility: National Hospital Organization Fukuokahigashi Medical Center ( Site 3849)
state: Fukuoka
city: Yanagawa
country: Japan
facility: Nagata Hospital ( Site 3815)
state: Fukuoka
city: Mizunami
country: Japan
facility: Tohno Chuo Clinic ( Site 3883)
state: Gifu
city: Shibukawa
country: Japan
facility: National Hospital Organization Shibukawa Medical Center ( Site 3843)
state: Gunma
city: Sapporo
country: Japan
facility: Idaimae Minamiyojo Int Clinic ( Site 3903)
state: Hokkaido
city: Himeji
country: Japan
facility: Terada Clinic Respiratory Medicine & General Practice ( Site 3907)
state: Hyogo
city: Itami
country: Japan
facility: Kinki Central Hospital ( Site 3910)
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center West Hospital ( Site 3868)
state: Hyogo
city: Higashiibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center ( Site 3846)
state: Ibaraki
city: Naka-gun
country: Japan
facility: National Hospital Organization Ibarakihigashi National Hospital ( Site 3917)
state: Ibaraki
city: Toride
country: Japan
facility: JA Toride Medical Center ( Site 3822)
state: Ibaraki
city: Tsuchiura
country: Japan
facility: National Hospital Organization Kasumigaura Medical Center ( Site 3844)
state: Ibaraki
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital ( Site 3915)
state: Ishikawa
city: Kanazawa
country: Japan
facility: Japan Community Health care Organization Kanazawa Hospital ( Site 3817)
state: Ishikawa
city: Komatsu
country: Japan
facility: Komatsu Municipal Hospital ( Site 3892)
state: Ishikawa
city: Takamatsu
country: Japan
facility: Kamei Internal Medicine and Respiratory Clinic ( Site 3904)
state: Kagawa
city: Fujisawa
country: Japan
facility: Fujisawa City Hospital ( Site 3891)
state: Kanagawa
city: Kawasaki
country: Japan
facility: Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 3878)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City Minato Red Cross Hospital ( Site 3906)
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Nanbu Hospital ( Site 3897)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center ( Site 3908)
state: Kanagawa
city: Matsusaka
country: Japan
facility: Matsusaka City Hospital ( Site 3825)
state: Mie
city: Matsumoto
country: Japan
facility: Koyama Medical Clinic ( Site 3838)
state: Nagano
city: Nagaoka
country: Japan
facility: Nagaoka Red Cross Hospital ( Site 3877)
state: Niigata
city: Tsukubo-gun
country: Japan
facility: National Hospital Organization Minami-Okayama Medical Center ( Site 3901)
state: Okayama
city: Higashiosaka
country: Japan
facility: Kawaguchi Respiratory Clinic ( Site 3890)
state: Osaka
city: Kishiwada
country: Japan
facility: Kishiwada City Hospital ( Site 3880)
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 3871)
state: Osaka
city: Sakai
country: Japan
facility: Sasaki Naika Clinic ( Site 3872)
state: Osaka
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3900)
state: Osaka
city: Kawaguchi
country: Japan
facility: Sugiura Clinic ( Site 3806)
state: Saitama
city: Matsue
country: Japan
facility: National Hospital Organization Matsue Medical Center ( Site 3848)
state: Shimane
city: Hamamatsu
country: Japan
facility: JapanOrganizationOfOccupationalHealthAndSafety HamamatsuRosaiHospital ( Site 3821)
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Hamamatsu Medical Center ( Site 3866)
state: Shizuoka
city: Hamamatsu
country: Japan
facility: National Hospital Organization Tenryu Hospital ( Site 3823)
state: Shizuoka
city: Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center ( Site 3911)
state: Tokyo
city: Kiyose
country: Japan
facility: National Hospital Organization Tokyo National Hospital ( Site 3909)
state: Tokyo
city: Kodaira
country: Japan
facility: Kiheibashi Otolaryngology ( Site 3828)
state: Tokyo
city: Shimonoseki
country: Japan
facility: Shimonoseki City Hospital ( Site 3902)
state: Yamaguchi
city: Akita
country: Japan
facility: Akita University Hospital ( Site 3851)
city: Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital ( Site 3874)
city: Gifu
country: Japan
facility: Gifu Prefectural General Medical Center ( Site 3824)
city: Kagoshima
country: Japan
facility: Tochigi Takao Clinic ( Site 3833)
city: Nagano
country: Japan
facility: Nagano Red Cross Hospital ( Site 3859)
city: Niigata
country: Japan
facility: Saiseikai Niigata Hospital ( Site 3831)
city: Oita
country: Japan
facility: Oita Red Cross Hospital ( Site 3837)
city: Oita
country: Japan
facility: Yamagata Clinic ( Site 3813)
city: Okinawa
country: Japan
facility: Chibana Clinic ( Site 3809)
city: Shizuoka
country: Japan
facility: Ito ENT Clinic ( Site 3816)
city: Tokyo
country: Japan
facility: Nihonbashi Egawa Clinic ( Site 3805)
city: Tokyo
country: Japan
facility: The Fraternity Memorial Hospital ( Site 3873)
city: Tokyo
country: Japan
facility: Showa University Hospital ( Site 3896)
city: Tokyo
country: Japan
facility: Ebisu Clinic Koukokukai Medical Corporation ( Site 3804)
city: Tokyo
country: Japan
facility: Kono Medical Clinic ( Site 3894)
city: Tokyo
country: Japan
facility: Medical Corporation Kouwakai Kouwa Clinic ( Site 3895)
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Geriatric Hospital ( Site 3905)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
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.