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

NCT ID: NCT03696108

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2020-10-07

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.

Conditions

Chronic Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gefapixant 15 mg BID

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

Group Type: EXPERIMENTAL

Gefapixant

Intervention Type: DRUG

Gefapixant 15 mg or 45 mg tablet administered orally BID

Placebo

Intervention Type: DRUG

Placebo matched to gefapixant 15 mg or 45 mg administered orally BID

Gefapixant 45 mg BID

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

Group Type: EXPERIMENTAL

Gefapixant

Intervention Type: DRUG

Gefapixant 15 mg or 45 mg tablet administered orally BID

Placebo

Intervention Type: DRUG

Placebo matched to gefapixant 15 mg or 45 mg administered orally BID

Interventions

Gefapixant

Gefapixant 15 mg or 45 mg tablet administered orally BID

Intervention Type: DRUG

Placebo

Placebo matched to gefapixant 15 mg or 45 mg administered orally BID

Intervention Type: DRUG

Other Intervention Names

MK-7264

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Chubu Rosai Hospital ( Site 3839)

Nagoya, Aichi-ken, Japan

National Hospital Organization Nagoya Medical Center ( Site 3898)

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital ( Site 3899)

Nagoya, Aichi-ken, Japan

Fukuoka University Chikushi Hospital ( Site 3886)

Chikushino-shi, Fukuoka, Japan

Oishi Clinic ( Site 3818)

Kasuya-gun, Fukuoka, Japan

National Hospital Organization Fukuokahigashi Medical Center ( Site 3849)

Koga, Fukuoka, Japan

Nagata Hospital ( Site 3815)

Yanagawa, Fukuoka, Japan

Tohno Chuo Clinic ( Site 3883)

Mizunami, Gifu, Japan

National Hospital Organization Shibukawa Medical Center ( Site 3843)

Shibukawa, Gunma, Japan

Idaimae Minamiyojo Int Clinic ( Site 3903)

Sapporo, Hokkaido, Japan

Terada Clinic Respiratory Medicine & General Practice ( Site 3907)

Himeji, Hyōgo, Japan

Kinki Central Hospital ( Site 3910)

Itami, Hyōgo, Japan

Kobe City Hospital Organization Kobe City Medical Center West Hospital ( Site 3868)

Kobe, Hyōgo, Japan

National Hospital Organization Mito Medical Center ( Site 3846)

Higashiibaraki-gun, Ibaraki, Japan

National Hospital Organization Ibarakihigashi National Hospital ( Site 3917)

Naka-gun, Ibaraki, Japan

JA Toride Medical Center ( Site 3822)

Toride, Ibaraki, Japan

National Hospital Organization Kasumigaura Medical Center ( Site 3844)

Tsuchiura, Ibaraki, Japan

Ishikawa Prefectural Central Hospital ( Site 3915)

Kanazawa, Ishikawa-ken, Japan

Japan Community Health care Organization Kanazawa Hospital ( Site 3817)

Kanazawa, Ishikawa-ken, Japan

Komatsu Municipal Hospital ( Site 3892)

Komatsu, Ishikawa-ken, Japan

Kamei Internal Medicine and Respiratory Clinic ( Site 3904)

Takamatsu, Kagawa-ken, Japan

Fujisawa City Hospital ( Site 3891)

Fujisawa, Kanagawa, Japan

Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 3878)

Kawasaki, Kanagawa, Japan

Yokohama City Minato Red Cross Hospital ( Site 3906)

Yokohama, Kanagawa, Japan

Saiseikai Yokohamashi Nanbu Hospital ( Site 3897)

Yokohama, Kanagawa, Japan

Kanagawa Cardiovascular and Respiratory Center ( Site 3908)

Yokohama, Kanagawa, Japan

Matsusaka City Hospital ( Site 3825)

Matsusaka, Mie-ken, Japan

Koyama Medical Clinic ( Site 3838)

Matsumoto, Nagano, Japan

Nagaoka Red Cross Hospital ( Site 3877)

Nagaoka, Niigata, Japan

National Hospital Organization Minami-Okayama Medical Center ( Site 3901)

Tsukubo-gun, Okayama-ken, Japan

Kawaguchi Respiratory Clinic ( Site 3890)

Higashiosaka, Osaka, Japan

Kishiwada City Hospital ( Site 3880)

Kishiwada, Osaka, Japan

Sasaki Naika Clinic ( Site 3872)

Sakai, Osaka, Japan

National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3900)

Sakai, Osaka, Japan

Kindai University Hospital ( Site 3871)

Sayama, Osaka, Japan

Sugiura Clinic ( Site 3806)

Kawaguchi, Saitama, Japan

National Hospital Organization Matsue Medical Center ( Site 3848)

Matsue, Shimane, Japan

JapanOrganizationOfOccupationalHealthAndSafety HamamatsuRosaiHospital ( Site 3821)

Hamamatsu, Shizuoka, Japan

Hamamatsu Medical Center ( Site 3866)

Hamamatsu, Shizuoka, Japan

National Hospital Organization Tenryu Hospital ( Site 3823)

Hamamatsu, Shizuoka, Japan

Tokyo Medical University Hachioji Medical Center ( Site 3911)

Hachiōji, Tokyo, Japan

National Hospital Organization Tokyo National Hospital ( Site 3909)

Kiyose, Tokyo, Japan

Kiheibashi Otolaryngology ( Site 3828)

Kodaira, Tokyo, Japan

Shimonoseki City Hospital ( Site 3902)

Shimonoseki, Yamaguchi, Japan

Akita University Hospital ( Site 3851)

Akita, , Japan

Fukui-ken Saiseikai Hospital ( Site 3874)

Fukui, , Japan

Gifu Prefectural General Medical Center ( Site 3824)

Gifu, , Japan

Tochigi Takao Clinic ( Site 3833)

Kagoshima, , Japan

Nagano Red Cross Hospital ( Site 3859)

Nagano, , Japan

Saiseikai Niigata Hospital ( Site 3831)

Niigata, , Japan

Chibana Clinic ( Site 3809)

Okinawa, , Japan

Oita Red Cross Hospital ( Site 3837)

Ōita, , Japan

Yamagata Clinic ( Site 3813)

Ōita, , Japan

Ito ENT Clinic ( Site 3816)

Shizuoka, , Japan

Nihonbashi Egawa Clinic ( Site 3805)

Tokyo, , Japan

The Fraternity Memorial Hospital ( Site 3873)

Tokyo, , Japan

Showa University Hospital ( Site 3896)

Tokyo, , 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

Tokyo Metropolitan Geriatric Hospital ( Site 3905)

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 35752582 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MK-7264-038

Identifier Type: OTHER

Identifier Source: secondary_id

184154

Identifier Type: REGISTRY

Identifier Source: secondary_id

7264-038

Identifier Type: -

Identifier Source: org_study_id