Trial · NCT03696108
A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)
NCT03696108, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2021-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038). Trials, record NCT03696108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03696108
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)
- NCT number
- NCT03696108
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 175 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chronic Cough
- Interventions
- Gefapixant, Placebo
- First posted
- 2018-10-04
- Last updated
- 2021-11-01
- Results first posted
- 2021-11-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced at Least One Adverse Event (AE) | Up to 54 Weeks | All randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Study Drug Due to an AE | Up to 52 Weeks | All randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 treatment and provided at least one baseline and one post-baseline endpoint observations during the treatment period. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in LCQ Total Score | Baseline, up to 52 Weeks | All randomized participants who have taken at least one dose of study treatment and provided at least one baseline and one post-baseline endpoint observations during the treatment period. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score | Baseline, Up to 52 Weeks | All randomized participants who have taken at least one dose of study treatment and provided at least one baseline and one post-baseline endpoint observations during the treatment period. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Event (AE) | Gefapixant 15 mg BID | 79 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | Gefapixant 45 mg | 82 | Participants | ||
| Number of Participants Who Discontinued Study Drug Due to an AE | Gefapixant 15 mg BID | 6 | Participants | ||
| Number of Participants Who Discontinued Study Drug Due to an AE | Gefapixant 45 mg | 17 | Participants | ||
| Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | Gefapixant 15 mg BID | 1.4 | 95% Confidence Interval 0.7 to 2.0 | Scores on a Scale | |
| Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | Gefapixant 45 mg | 0.9 | 95% Confidence Interval 0.3 to 1.6 | Scores on a Scale | |
| Change From Baseline in LCQ Total Score | Gefapixant 15 mg BID | Week 4 | 0.9 | 95% Confidence Interval 0.2 to 1.5 | Scores on a Scale |
| Change From Baseline in LCQ Total Score | Gefapixant 45 mg | Week 4 | 0.8 | 95% Confidence Interval 0.2 to 1.4 | Scores on a Scale |
| Change From Baseline in LCQ Total Score | Gefapixant 15 mg BID | Week 8 | 1.5 | 95% Confidence Interval 0.8 to 2.1 | Scores on a Scale |
| Change From Baseline in LCQ Total Score | Gefapixant 45 mg | Week 8 | 1.2 | 95% Confidence Interval 0.6 to 1.9 | Scores on a Scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gefapixant 15 mg BID | 84 | |
| Overall Study | STARTED | Gefapixant 45 mg BID | 85 | |
| Overall Study | COMPLETED | Gefapixant 15 mg BID | 80 | |
| Overall Study | COMPLETED | Gefapixant 45 mg BID | 79 | |
| Overall Study | NOT COMPLETED | Gefapixant 15 mg BID | 4 | |
| Overall Study | NOT COMPLETED | Gefapixant 45 mg BID | 6 |
Source ClinicalTrials.gov
Adverse events58
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 | Constipation | Gastrointestinal disorders | Gefapixant 15 mg | 6 | 84 | 6 |
| other | Constipation | Gastrointestinal disorders | Gefapixant 45 mg | 2 | 85 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 15 mg | 7 | 84 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 45 mg | 2 | 85 | 2 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Gefapixant 15 mg | 6 | 84 | 6 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Gefapixant 45 mg | 1 | 85 | 1 |
| other | Paraesthesia oral | Gastrointestinal disorders | Gefapixant 15 mg | 1 | 84 | 1 |
| other | Paraesthesia oral | Gastrointestinal disorders | Gefapixant 45 mg | 5 | 85 | 5 |
| other | Pyrexia | General disorders | Gefapixant 15 mg | 5 | 84 | 5 |
| other | Pyrexia | General disorders | Gefapixant 45 mg | 6 | 85 | 7 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gefapixant 15 mg | 0 | 84 |
| Total, all-cause mortality | Gefapixant 45 mg | 0 | 85 |
| Total, other adverse events | Gefapixant 15 mg | 73 | 84 |
| Total, other adverse events | Gefapixant 45 mg | 76 | 85 |
| Total, serious adverse events | Gefapixant 15 mg | 2 | 84 |
| Total, serious adverse events | Gefapixant 45 mg | 10 | 85 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35752582 | DERIVED |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gefapixant 15 mg BID vs Gefapixant 45 mg: Number of Participants Who Experienced at Least One Adverse Event (AE) | Trial comparisons |
| Gefapixant 15 mg BID vs Gefapixant 45 mg: Number of Participants Who Discontinued Study Drug Due to an AE | Trial comparisons |
| Gefapixant 15 mg vs Gefapixant 45 mg: deaths from any cause | Trial comparisons |
| Gefapixant 15 mg vs Gefapixant 45 mg: 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/NCT03696108
GET https://conductscience.org/api/trials/v1/NCT03696108/results?page=2