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

NCT03696108 | Completed Phase 3 Results

• 3 other identifiers: 7264-038MK-7264-038184154
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 61

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12

  Baseline, Week 12

• Change From Baseline in LCQ Total Score

  Baseline, up to 52 Weeks

• Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score

  Baseline, Up to 52 Weeks

Study Arms (2)

Gefapixant 15 mg BID

EXPERIMENTAL

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

Drug: Gefapixant; Drug: Placebo

Gefapixant 45 mg BID

EXPERIMENTAL

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

Drug: Gefapixant; Drug: Placebo

Interventions

Gefapixant DRUG

Gefapixant 15 mg or 45 mg tablet administered orally BID

Also known as: MK-7264

Gefapixant 15 mg BID; Gefapixant 45 mg BID

Placebo DRUG

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

Gefapixant 15 mg BID; Gefapixant 45 mg BID

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (61)

Chubu Rosai Hospital ( Site 3839)

Nagoya, Aichi-ken, 455-8530, Japan

Location

National Hospital Organization Nagoya Medical Center ( Site 3898)

Nagoya, Aichi-ken, 460-0001, Japan

Location

Nagoya City University Hospital ( Site 3899)

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fukuoka University Chikushi Hospital ( Site 3886)

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Oishi Clinic ( Site 3818)

Kasuya-gun, Fukuoka, 811-2310, Japan

Location

National Hospital Organization Fukuokahigashi Medical Center ( Site 3849)

Koga, Fukuoka, 811-3195, Japan

Location

Nagata Hospital ( Site 3815)

Yanagawa, Fukuoka, 832-0059, Japan

Location

Tohno Chuo Clinic ( Site 3883)

Mizunami, Gifu, 509-6134, Japan

Location

National Hospital Organization Shibukawa Medical Center ( Site 3843)

Shibukawa, Gunma, 377-0280, Japan

Location

Idaimae Minamiyojo Int Clinic ( Site 3903)

Sapporo, Hokkaido, 064-0804, Japan

Location

Terada Clinic Respiratory Medicine & General Practice ( Site 3907)

Himeji, Hyōgo, 670-0849, Japan

Location

Kinki Central Hospital ( Site 3910)

Itami, Hyōgo, 664-8533, Japan

Location

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

Kobe, Hyōgo, 653-0013, Japan

Location

National Hospital Organization Mito Medical Center ( Site 3846)

Higashiibaraki-gun, Ibaraki, 311-3193, Japan

Location

National Hospital Organization Ibarakihigashi National Hospital ( Site 3917)

Naka-gun, Ibaraki, 319-1113, Japan

Location

JA Toride Medical Center ( Site 3822)

Toride, Ibaraki, 302-0022, Japan

Location

National Hospital Organization Kasumigaura Medical Center ( Site 3844)

Tsuchiura, Ibaraki, 300-8585, Japan

Location

Ishikawa Prefectural Central Hospital ( Site 3915)

Kanazawa, Ishikawa-ken, 920-8530, Japan

Location

Japan Community Health care Organization Kanazawa Hospital ( Site 3817)

Kanazawa, Ishikawa-ken, 920-8610, Japan

Location

Komatsu Municipal Hospital ( Site 3892)

Komatsu, Ishikawa-ken, 923-8560, Japan

Location

Kamei Internal Medicine and Respiratory Clinic ( Site 3904)

Takamatsu, Kagawa-ken, 761-8073, Japan

Location

Fujisawa City Hospital ( Site 3891)

Fujisawa, Kanagawa, 251-8550, Japan

Location

Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 3878)

Kawasaki, Kanagawa, 210-0852, Japan

Location

Yokohama City Minato Red Cross Hospital ( Site 3906)

Yokohama, Kanagawa, 231-8682, Japan

Location

Saiseikai Yokohamashi Nanbu Hospital ( Site 3897)

Yokohama, Kanagawa, 234-8503, Japan

Location

Kanagawa Cardiovascular and Respiratory Center ( Site 3908)

Yokohama, Kanagawa, 236-0051, Japan

Location

Matsusaka City Hospital ( Site 3825)

Matsusaka, Mie-ken, 515-8544, Japan

Location

Koyama Medical Clinic ( Site 3838)

Matsumoto, Nagano, 390-0872, Japan

Location

Nagaoka Red Cross Hospital ( Site 3877)

Nagaoka, Niigata, 940-2085, Japan

Location

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

Tsukubo-gun, Okayama-ken, 701-0304, Japan

Location

Kawaguchi Respiratory Clinic ( Site 3890)

Higashiosaka, Osaka, 577-0843, Japan

Location

Kishiwada City Hospital ( Site 3880)

Kishiwada, Osaka, 596-8501, Japan

Location

Sasaki Naika Clinic ( Site 3872)

Sakai, Osaka, 591-8037, Japan

Location

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

Sakai, Osaka, 591-8555, Japan

Location

Kindai University Hospital ( Site 3871)

Sayama, Osaka, 589-8511, Japan

Location

Sugiura Clinic ( Site 3806)

Kawaguchi, Saitama, 332-0012, Japan

Location

National Hospital Organization Matsue Medical Center ( Site 3848)

Matsue, Shimane, 690-8556, Japan

Location

JapanOrganizationOfOccupationalHealthAndSafety HamamatsuRosaiHospital ( Site 3821)

Hamamatsu, Shizuoka, 430-8525, Japan

Location

Hamamatsu Medical Center ( Site 3866)

Hamamatsu, Shizuoka, 432-8580, Japan

Location

National Hospital Organization Tenryu Hospital ( Site 3823)

Hamamatsu, Shizuoka, 434-8511, Japan

Location

Tokyo Medical University Hachioji Medical Center ( Site 3911)

Hachiōji, Tokyo, 193-0998, Japan

Location

National Hospital Organization Tokyo National Hospital ( Site 3909)

Kiyose, Tokyo, 204-8585, Japan

Location

Kiheibashi Otolaryngology ( Site 3828)

Kodaira, Tokyo, 187-0044, Japan

Location

Shimonoseki City Hospital ( Site 3902)

Shimonoseki, Yamaguchi, 750-8520, Japan

Location

Akita University Hospital ( Site 3851)

Akita, 010-8543, Japan

Location

Fukui-ken Saiseikai Hospital ( Site 3874)

Fukui, 918-8503, Japan

Location

Gifu Prefectural General Medical Center ( Site 3824)

Gifu, 500-8717, Japan

Location

Tochigi Takao Clinic ( Site 3833)

Kagoshima, 890-0073, Japan

Location

Nagano Red Cross Hospital ( Site 3859)

Nagano, 380-8582, Japan

Location

Saiseikai Niigata Hospital ( Site 3831)

Niigata, 950-1104, Japan

Location

Chibana Clinic ( Site 3809)

Okinawa, 904-2143, Japan

Location

Oita Red Cross Hospital ( Site 3837)

Ōita, 870-0033, Japan

Location

Yamagata Clinic ( Site 3813)

Ōita, 870-0921, Japan

Location

Ito ENT Clinic ( Site 3816)

Shizuoka, 420-0803, Japan

Location

Nihonbashi Egawa Clinic ( Site 3805)

Tokyo, 103-0028, Japan

Location

The Fraternity Memorial Hospital ( Site 3873)

Tokyo, 130-8587, Japan

Location

Showa University Hospital ( Site 3896)

Tokyo, 142-8666, Japan

Location

Ebisu Clinic Koukokukai Medical Corporation ( Site 3804)

Tokyo, 150-0013, Japan

Location

Kono Medical Clinic ( Site 3894)

Tokyo, 157-0072, Japan

Location

Medical Corporation Kouwakai Kouwa Clinic ( Site 3895)

Tokyo, 170-0003, Japan

Location

Tokyo Metropolitan Geriatric Hospital ( Site 3905)

Tokyo, 173-0015, Japan

Location

Related Publications (1)

• 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.

  PMID: 35752582 DERIVED

MeSH Terms

Conditions

Chronic Cough

Interventions

Gefapixant

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 4, 2018
• Study Start: October 31, 2018
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: November 1, 2021
• Results First Posted: November 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (61)