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

Phase 3

Completed

• Conditions: Chronic Cough
• Interventions: Drug: Gefapixant; Drug: Placebo

• 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

Study Timeline

• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Study Start: 2018-10-31
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07
• Status Verified: 2021-08
• Results First Submitted: 2021-09-30
• Results First Submitted QC: 2021-09-30
• Last Update Submitted: 2021-09-30
• Results First Posted: 2021-11-01
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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.

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)

Chubu Rosai Hospital ( Site 3839); 🇯🇵 Nagoya, Aichi, Japan

National Hospital Organization Nagoya Medical Center ( Site 3898); 🇯🇵 Nagoya, Aichi, Japan

Nagoya City University Hospital ( Site 3899); 🇯🇵 Nagoya, Aichi, Japan

Fukuoka University Chikushi Hospital ( Site 3886); 🇯🇵 Chikushino, 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

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