Phase 3
N=419
Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
Chronic Cough
Bottom Line
View on ClinicalTrials.gov: NCT04193202 ↗Enrolled (actual)
419
Serious AEs
1.7%
Results posted
Oct 2022
Primary outcome: Primary: Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 — 4.34; 3.59 Scores on a Scale — p=0.034
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gefapixant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 |
4.34; 3.59 | 0.034 sig |
| SECONDARY Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12 |
-31.79; -24.87 | 0.006 sig |
| SECONDARY Percentage of Participants With One or More Adverse Events (AEs) |
65.5; 43.1 | — |
| SECONDARY Percentage of Participants Who Discontinue Study Drug Due to an AE |
11.2; 1.9 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration >8 weeks after onset of cough symptoms) for <12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.
Eligibility Criteria
Inclusion Criteria
- Chest radiograph or CT thorax (within 1 year of Screening/Visit 1 and after the onset of chronic cough) 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 subinvestigator
- Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for 1 tablespoon of phlegm, that occurs every day for at least 3 months in a row
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or cervical cancer
- Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
- Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide-containing drugs
- Has a known allergy to gefapixant or its excipients
- Has donated or lost ≥1 unit (~300 mL) of blood within 8 weeks prior to first dose of gefapixant
- Has previously received gefapixant
- Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study
Data sourced from ClinicalTrials.gov (NCT04193202). 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.