Trial · NCT04193202
Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
NCT04193202, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2022-10-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043). Trials, record NCT04193202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04193202
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
- NCT number
- NCT04193202
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 419 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chronic Cough
- Interventions
- Gefapixant, Placebo
- First posted
- 2019-12-10
- Last updated
- 2023-05-16
- Other registries' IDs
- eudract:2019-002308-42
- Results first posted
- 2022-10-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | Baseline, Week 12 | 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 score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated. |
| Secondary | Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12 | Baseline, Week 12 | Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score is calculated. |
| Secondary | Percentage of Participants With One or More Adverse Events (AEs) | Up to approximately 14 weeks | An AE is defined as 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. The percentage of participants with one or more AEs is presented. |
| Secondary | Percentage of Participants Who Discontinue Study Drug Due to an AE | Up to approximately 12 weeks | An AE is defined as 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. The percentage of participants who discontinue study drug due to an AE is presented. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | Baseline, Week 12 | All randomized participants who have taken at least one dose of study intervention, and had LCQ total score values at both baseline and week 12. Participants were analyzed in the group as randomized. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12 | Baseline, Week 12 | All randomized participants who have taken at least one dose of study intervention, and had VAS total score values at both baseline and week 12. Participants were analyzed in the group as randomized. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With One or More Adverse Events (AEs) | Up to approximately 14 weeks | All randomized participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Discontinue Study Drug Due to an AE | Up to approximately 12 weeks | All randomized participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | Gefapixant | 4.34 | 95% Confidence Interval 3.84 to 4.83 | Scores on a Scale | |
| Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | Placebo | 3.59 | 95% Confidence Interval 3.09 to 4.09 | Scores on a Scale | |
| Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12 | Gefapixant | -31.79 | 95% Confidence Interval -35.37 to -28.20 | Scores on a Scale | |
| Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12 | Placebo | -24.87 | 95% Confidence Interval -28.41 to -21.32 | Scores on a Scale | |
| Percentage of Participants With One or More Adverse Events (AEs) | Gefapixant | 65.5 | Percentage of Participants | ||
| Percentage of Participants With One or More Adverse Events (AEs) | Placebo | 43.1 | Percentage of Participants | ||
| Percentage of Participants Who Discontinue Study Drug Due to an AE | Gefapixant | 11.2 | Percentage of Participants | ||
| Percentage of Participants Who Discontinue Study Drug Due to an AE | Placebo | 1.9 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gefapixant | 208 | |
| Overall Study | STARTED | Placebo | 211 | |
| Overall Study | Treated | Gefapixant | 206 | |
| Overall Study | Treated | Placebo | 209 | |
| Overall Study | COMPLETED | Gefapixant | 192 | |
| Overall Study | COMPLETED | Placebo | 201 | |
| Overall Study | NOT COMPLETED | Gefapixant | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 10 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ageusia | Nervous system disorders | Gefapixant | 24 | 206 | 24 |
| other | Ageusia | Nervous system disorders | Placebo | 0 | 209 | 0 |
| other | Dysgeusia | Nervous system disorders | Gefapixant | 66 | 206 | 70 |
| other | Dysgeusia | Nervous system disorders | Placebo | 7 | 209 | 7 |
| other | Headache | Nervous system disorders | Gefapixant | 11 | 206 | 12 |
| other | Headache | Nervous system disorders | Placebo | 14 | 209 | 15 |
| other | Hypogeusia | Nervous system disorders | Gefapixant | 22 | 206 | 22 |
| other | Hypogeusia | Nervous system disorders | Placebo | 1 | 209 | 1 |
| serious | Myocardial ischaemia | Cardiac disorders | Gefapixant | 1 | 206 | 1 |
| serious | Myocardial ischaemia | Cardiac disorders | Placebo | 0 | 209 | 0 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gefapixant | 0 | 208 |
| Total, all-cause mortality | Placebo | 1 | 211 |
| Total, other adverse events | Gefapixant | 105 | 206 |
| Total, other adverse events | Placebo | 22 | 209 |
| Total, serious adverse events | Gefapixant | 3 | 206 |
| Total, serious adverse events | Placebo | 4 | 209 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36879087 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gefapixant vs Placebo: deaths from any cause | Trial comparisons |
| Gefapixant vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04193202
GET https://conductscience.org/api/trials/v1/NCT04193202/events?page=2