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NCT04193202 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 419
- Enrollment target
NCT04193202: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT04193202 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 419 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04193202, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 419 participants
- Enrollment target
Study 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.
Primary Outcome
Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total scor
Interventions
- DRUG Placebo
- DRUG Gefapixant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 419 participants |
| Start Date | 2020-05-21 |
| Est. Completion | 2021-11-03 |
| Phase | Phase 3 |
What the finished NCT04193202 record still lists
NCT04193202 is an interventional study that assigns participants to a tested intervention. The registered 419 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04193202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04193202 about?
NCT04193202 is a clinical study titled "Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)". 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 s...
What is the current status of trial NCT04193202?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 419 participants. The study started on 2020-05-21. Estimated completion is 2021-11-03.
What interventions are being tested in trial NCT04193202?
The interventions under investigation include: Placebo (DRUG), Gefapixant (DRUG).
Who is sponsoring clinical trial NCT04193202?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04193202's enrollment target sits among peer trials
419 899th of 2000 higher than 1,101 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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