Trial · NCT03449147
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)
NCT03449147, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2021-09-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030). Trials, record NCT03449147. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03449147
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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 Adult Participants With Chronic Cough (MK-7264-030)
- NCT number
- NCT03449147
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,317 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chronic Cough
- Interventions
- Placebo, Gefapixant 15 mg BID, Gefapixant 45 mg BID
- First posted
- 2018-02-28
- Last updated
- 2021-09-02
- Other registries' IDs
- eudract:2017-003559-49
- Results first posted
- 2021-09-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline | Baseline, Week 24 | 24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported. |
| Primary | Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | 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 a 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 | Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline | Baseline, Week 24 | Awake coughs per hour was defined as the average hourly cough frequency while the participant is awake, based on a 24-hour interval of sound recordings using a digital recording device (cough monitor). ANCOVA model was applied to log-transformed cough data to determine GM of awake coughs per hour at baseline and week 24. The GMR (Week 24 GM awake coughs per hour divided by Baseline GM awake coughs per hour) is reported. |
| Secondary | Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24 | Baseline, Week 24 | The 19-item LCQ assessed the impact of chronic cough in three health-related quality of life (HRQoL) domains (physical, social and psychological). The LCQ is calculated as a mean score for each domain ranging from 1 to 7, with a total score ranging from 3 to 21. 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 Week 24. The percentage of participants (logistic regression model-based) with a ≥1.3-point increase in the LCQ total score at Week 24 is presented. |
| Secondary | Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24 | Baseline, Week 24 | 24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A clinically meaningful improvement from baseline is defined as a ≤-30% change (≥30% reduction) in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 24 (≥30% reduction from baseline) is presented. |
| Secondary | Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24 | Baseline, Week 24 | The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-1.3 point change from baseline in CSD at Week 24 (or ≥1.3 point reduction from baseline) is reported. |
| Secondary | Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24 | Baseline, Week 24 | The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-2.7 point change from baseline in CSD at Week 24 (or ≥2.7 point reduction from baseline) is reported. |
| Secondary | Percentage of Participants With a ≤-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24 | Baseline, Week 24 | The VAS is a single-item questionnaire with the response on a 100- point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was defined as the average of the VAS scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-30 mm change from baseline in cough severity VAS score at Week 24 is reported. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline | Baseline, Week 24 | All randomized participants who took at least 1 dose of study intervention, had available 24-hour cough data at baseline and at least one available post-baseline measurement during the treatment period. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | Up to 54 Weeks | All randomized participants who received at least one dose of study intervention during the 52-week treatment period. Per protocol, participants in the optional off-treatment observational period were not included. 3 participants randomized to placebo group who took 1 or more incorrect dose(s) of study drug were counted in the higher dose group of gefapixant received: 2 participants were analyzed in the gefapixant 15 mg group and 1 was analyzed in the gefapixant 45 mg group. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued a Study Drug Due to an AE | Up to 52 weeks | All randomized participants who received at least one dose of study intervention during the 52-week treatment period. Per protocol, participants in the optional off-treatment observational period were not included. 3 participants randomized to placebo group who took 1 or more incorrect dose(s) of study drug were counted in the higher dose group of gefapixant received: 2 participants were analyzed in the gefapixant 15 mg group and 1 was analyzed in the gefapixant 45 mg group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline | Baseline, Week 24 | All randomized participants who took at least 1 dose of study intervention, had available awake 24-hour cough data at baseline and at least one available post-baseline measurement during the treatment period. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24 | Baseline, Week 24 | All randomized participants who had taken at least 1 dose of study intervention, had available LCQ data at baseline, and at least one available post-baseline measurement in the treatment period. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24 | Baseline, Week 24 | All randomized participants who took at least 1 dose of study intervention, had available 24-hour cough data at baseline and at least one available post-baseline measurement in the treatment period. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24 | Baseline, Week 24 | All randomized participants who had taken at least 1 dose of study intervention, had available CSD data at baseline, and at least one available post-baseline measurement in the treatment period. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24 | Baseline, Week 24 | All randomized participants who had taken at least 1 dose of study intervention, had available CSD data at baseline, and at least one available post-baseline measurement in the treatment period. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≤-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24 | Baseline, Week 24 | All randomized participants who had taken at least 1 dose of study intervention, had available VAS data at baseline, and at least one available post-baseline measurement in the treatment period. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline | Placebo | 0.43 | 95% Confidence Interval 0.39 to 0.48 | Ratio | |
| Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline | Gefapixant 15 mg BID | 0.43 | 95% Confidence Interval 0.38 to 0.47 | Ratio | |
| Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline | Gefapixant 45 mg BID | 0.37 | 95% Confidence Interval 0.33 to 0.41 | Ratio | |
| Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | Placebo | 349 | Participants | ||
| Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | Gefapixant 15 mg BID | 373 | Participants | ||
| Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | Gefapixant 45 mg BID | 399 | Participants | ||
| Number of Participants Who Discontinued a Study Drug Due to an AE | Placebo | 25 | Participants | ||
| Number of Participants Who Discontinued a Study Drug Due to an AE | Gefapixant 15 mg BID | 40 | Participants | ||
| Number of Participants Who Discontinued a Study Drug Due to an AE | Gefapixant 45 mg BID | 100 | Participants | ||
| Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline | Placebo | 0.42 | 95% Confidence Interval 0.38 to 0.47 | Ratio |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 52-week Treatment Period | STARTED | Placebo | 436 | |
| 52-week Treatment Period | STARTED | Gefapixant 15 mg BID | 442 | |
| 52-week Treatment Period | STARTED | Gefapixant 45 mg BID | 439 | |
| 52-week Treatment Period | COMPLETED | Placebo | 382 | |
| 52-week Treatment Period | COMPLETED | Gefapixant 15 mg BID | 368 | |
| 52-week Treatment Period | COMPLETED | Gefapixant 45 mg BID | 355 | |
| 52-week Treatment Period | NOT COMPLETED | Placebo | 54 | |
| 52-week Treatment Period | NOT COMPLETED | Gefapixant 15 mg BID | 74 | |
| 52-week Treatment Period | NOT COMPLETED | Gefapixant 45 mg BID | 84 | |
| 12-Week Off-Treatment Durability Period | STARTED | Placebo | 48 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events576
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 | Diarrhoea | Gastrointestinal disorders | Placebo | 18 | 432 | 20 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 15 mg BID | 27 | 442 | 29 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 45 mg BID | 27 | 440 | 34 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo: Off Tx | 0 | 48 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 15 mg BID: Off Tx | 0 | 37 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 45 mg BID: Off Tx | 0 | 37 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 11 | 432 | 12 |
| other | Dry mouth | Gastrointestinal disorders | Gefapixant 15 mg BID | 15 | 442 | 15 |
| other | Dry mouth | Gastrointestinal disorders | Gefapixant 45 mg BID | 32 | 440 | 34 |
| other | Dry mouth | Gastrointestinal disorders | Placebo: Off Tx | 0 | 48 | 0 |
1 to 10 of 576Source ClinicalTrials.gov
See all 576 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 433 |
| Total, all-cause mortality | Gefapixant 15 mg BID | 1 | 444 |
| Total, all-cause mortality | Gefapixant 45 mg BID | 0 | 440 |
| Total, all-cause mortality | Placebo: Off Tx | 0 | 48 |
| Total, all-cause mortality | Gefapixant 15 mg BID: Off Tx | 0 | 37 |
| Total, all-cause mortality | Gefapixant 45 mg BID: Off Tx | 0 | 37 |
| Total, other adverse events | Placebo | 248 | 432 |
| Total, other adverse events | Gefapixant 15 mg BID | 290 | 442 |
| Total, other adverse events | Gefapixant 45 mg BID | 359 | 440 |
| Total, other adverse events | Placebo: Off Tx | 6 | 48 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03449147
GET https://conductscience.org/api/trials/v1/NCT03449147/results?page=2