Phase 3
Completed N=169
A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)
Source: ClinicalTrials.gov NCT03696108 ↗Enrolled (actual)
169
Serious AEs
7.1%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants Who Experienced at Least One Adverse Event (AE) — 79; 82 Participants
◆ Published Evidence
Emerging
14citations · ~4 / year
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.
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.
Linked Publications
-
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced at Least One Adverse Event (AE) |
79; 82 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE |
6; 17 | — |
| SECONDARY Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 |
1.4; 0.9 | — |
| SECONDARY Change From Baseline in LCQ Total Score |
0.9; 0.8; 1.5; 1.2; 1.4; 0.9 | — |
| SECONDARY Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score |
38.1; 36.5; 43.4; 43.2; 48.2; 40.7 | — |
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) 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.
Data sourced from ClinicalTrials.gov (NCT03696108) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.