A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)
- Registration Number
- NCT03696108
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gefapixant 15 mg BID Gefapixant Participants will receive gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg twice daily (BID) during the study period (52 weeks). Gefapixant 15 mg BID Placebo Participants will receive gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg twice daily (BID) during the study period (52 weeks). Gefapixant 45 mg BID Gefapixant Participants will receive gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the study period (52 weeks). Gefapixant 45 mg BID Placebo Participants will receive gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the study period (52 weeks).
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced at Least One Adverse Event (AE) Up to 54 Weeks 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 Up to 52 Weeks 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
Name Time Method Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score Baseline, Up to 52 Weeks 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.
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 Baseline, 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 Baseline, up to 52 Weeks 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.
Trial Locations
- Locations (61)
Fukuoka University Chikushi Hospital ( Site 3886)
🇯🇵Chikushino, Fukuoka, Japan
National Hospital Organization Nagoya Medical Center ( Site 3898)
🇯🇵Nagoya, Aichi, Japan
Nagoya City University Hospital ( Site 3899)
🇯🇵Nagoya, Aichi, Japan
Chubu Rosai Hospital ( Site 3839)
🇯🇵Nagoya, Aichi, Japan
National Hospital Organization Ibarakihigashi National Hospital ( Site 3917)
🇯🇵Naka-gun, Ibaraki, Japan
Kobe City Hospital Organization Kobe City Medical Center West Hospital ( Site 3868)
🇯🇵Kobe, Hyogo, Japan
Idaimae Minamiyojo Int Clinic ( Site 3903)
🇯🇵Sapporo, Hokkaido, Japan
National Hospital Organization Shibukawa Medical Center ( Site 3843)
🇯🇵Shibukawa, Gunma, Japan
Tochigi Takao Clinic ( Site 3833)
🇯🇵Kagoshima, Japan
Saiseikai Yokohamashi Nanbu Hospital ( Site 3897)
🇯🇵Yokohama, Kanagawa, Japan
Medical Corporation Kouwakai Kouwa Clinic ( Site 3895)
🇯🇵Tokyo, Japan
Kinki Central Hospital ( Site 3910)
🇯🇵Itami, Hyogo, Japan
Yokohama City Minato Red Cross Hospital ( Site 3906)
🇯🇵Yokohama, Kanagawa, Japan
Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 3878)
🇯🇵Kawasaki, Kanagawa, Japan
Oishi Clinic ( Site 3818)
🇯🇵Kasuya-gun, Fukuoka, Japan
National Hospital Organization Fukuokahigashi Medical Center ( Site 3849)
🇯🇵Koga, Fukuoka, Japan
Terada Clinic Respiratory Medicine & General Practice ( Site 3907)
🇯🇵Himeji, Hyogo, Japan
Nagata Hospital ( Site 3815)
🇯🇵Yanagawa, Fukuoka, Japan
Tohno Chuo Clinic ( Site 3883)
🇯🇵Mizunami, Gifu, Japan
National Hospital Organization Mito Medical Center ( Site 3846)
🇯🇵Higashiibaraki-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, Japan
Japan Community Health care Organization Kanazawa Hospital ( Site 3817)
🇯🇵Kanazawa, Ishikawa, Japan
Komatsu Municipal Hospital ( Site 3892)
🇯🇵Komatsu, Ishikawa, Japan
Kamei Internal Medicine and Respiratory Clinic ( Site 3904)
🇯🇵Takamatsu, Kagawa, Japan
Fujisawa City Hospital ( Site 3891)
🇯🇵Fujisawa, Kanagawa, Japan
Koyama Medical Clinic ( Site 3838)
🇯🇵Matsumoto, Nagano, Japan
Matsusaka City Hospital ( Site 3825)
🇯🇵Matsusaka, Mie, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 3908)
🇯🇵Yokohama, Kanagawa, Japan
Nagaoka Red Cross Hospital ( Site 3877)
🇯🇵Nagaoka, Niigata, Japan
National Hospital Organization Minami-Okayama Medical Center ( Site 3901)
🇯🇵Tsukubo-gun, Okayama, Japan
Kawaguchi Respiratory Clinic ( Site 3890)
🇯🇵Higashiosaka, Osaka, Japan
Kindai University Hospital ( Site 3871)
🇯🇵Osakasayama, Osaka, Japan
Kishiwada City Hospital ( Site 3880)
🇯🇵Kishiwada, Osaka, Japan
Sasaki Naika Clinic ( Site 3872)
🇯🇵Sakai, Osaka, Japan
Sugiura Clinic ( Site 3806)
🇯🇵Kawaguchi, Saitama, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3900)
🇯🇵Sakai, Osaka, Japan
JapanOrganizationOfOccupationalHealthAndSafety HamamatsuRosaiHospital ( Site 3821)
🇯🇵Hamamatsu, Shizuoka, Japan
Hamamatsu Medical Center ( Site 3866)
🇯🇵Hamamatsu, Shizuoka, Japan
Shimonoseki City Hospital ( Site 3902)
🇯🇵Shimonoseki, Yamaguchi, Japan
National Hospital Organization Tenryu Hospital ( Site 3823)
🇯🇵Hamamatsu, Shizuoka, Japan
National Hospital Organization Tokyo National Hospital ( Site 3909)
🇯🇵Kiyose, Tokyo, Japan
Kiheibashi Otolaryngology ( Site 3828)
🇯🇵Kodaira, Tokyo, 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
Nagano Red Cross Hospital ( Site 3859)
🇯🇵Nagano, 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
Nihonbashi Egawa Clinic ( Site 3805)
🇯🇵Tokyo, Japan
The Fraternity Memorial Hospital ( Site 3873)
🇯🇵Tokyo, Japan
Ito ENT Clinic ( Site 3816)
🇯🇵Shizuoka, Japan
Showa University Hospital ( Site 3896)
🇯🇵Tokyo, Japan
Ebisu Clinic Koukokukai Medical Corporation ( Site 3804)
🇯🇵Tokyo, Japan
Kono Medical Clinic ( Site 3894)
🇯🇵Tokyo, Japan
Tokyo Metropolitan Geriatric Hospital ( Site 3905)
🇯🇵Tokyo, Japan
National Hospital Organization Matsue Medical Center ( Site 3848)
🇯🇵Matsue, Shimane, Japan
Tokyo Medical University Hachioji Medical Center ( Site 3911)
🇯🇵Hachioji, Tokyo, Japan