Trial · NCT03449134
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)
NCT03449134, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2021-06-16
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-7264-027). Trials, record NCT03449134. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03449134
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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-7264-027)
- NCT number
- NCT03449134
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 732 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chronic Cough
- Interventions
- Placebo, Gefapixant
- First posted
- 2018-02-28
- Last updated
- 2021-06-16
- Other registries' IDs
- eudract:2017-000537-31
- Results first posted
- 2021-06-16
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 Objective Coughs Per Hour (Week 12/Baseline) | Baseline, Week 12 | 24-hour objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually \<24 hours but ≥20 hours). Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough counts to determine geometric mean (GM) 24-hour objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM 24-hour objective coughs per hour divided by the Baseline GM 24-hour objective coughs per hour was reported for all treatment study arms. |
| Primary | Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up | Up to approximately 54 weeks | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with at least one AE during either the 52-week treatment period or 2-week telephone follow-up was reported for all treatment study arms. |
| Primary | Number of Participants Who Discontinued Treatment Due to AEs | Up to approximately 52 weeks | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention during the 52-week treatment period due to an AE for which the action taken was listed as 'drug withdrawn' was reported for all treatment study arms. |
| Secondary | Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline) | Baseline, Week 12 | Awake objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) while the participant is awake divided by the total duration (in hours) for the monitoring period that the participant was awake. Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal ANCOVA model was applied to log-transformed cough counts to determine GM awake objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM awake objective coughs per hour divided by the Baseline GM awake objective coughs per hour was reported for all treatment study arms. |
| Secondary | Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at Week 12 | Baseline, Week 12 | 24-hour coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually \<24 hours but ≥20 hours). Assessment based on 24-hour sound recordings using a digital recording device. Percent change in 24-hour coughs per hour = (change from baseline in 24-hour coughs per hour / baseline 24-hour coughs per hour) ×100%. Negative values indicate a decrease in cough rate, while positive values indicate an increase in cough rate. A participant was considered a responder if the percent change from baseline in 24-hour coughs per hour was ≤ -30% (or a ≥30% reduction from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 12 (≥30% reduction from baseline) was reported for all treatment study arms. |
| Secondary | Percentage of Participants (Model-Based) With a ≤ -1.3-point Change From Baseline in Mean Weekly Cough Severity Diary (CSD) Total Score at Week 12 | Baseline, Week 12 | The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores 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 total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -1.3 points (or a ≥1.3 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -1.3 point change from baseline in CSD at Week 12 (or ≥1.3 point reduction from baseline) was reported for all treatment study arms. |
| Secondary | Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at Week 12 | Baseline, Week 12 | The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores 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 total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -2.7 points (or a ≥2.7 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -2.7 point change from baseline in CSD at Week 12 (or ≥2.7 point reduction from baseline) was reported for all treatment study arms. |
| Secondary | Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 12 | Baseline, Week 12 | Cough severity was scored using the Cough Severity VAS, a single-item question asking the participant to rate the severity of their cough "today" using a 100 mm VAS (100-point scale) ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was derived as the average of VAS scores collected during the week prior to each visit. Baseline was defined as the average VAS scores collected during the week prior to Day 1 (Day -6 to Day 0). A participant was considered a responder if the change from baseline in mean weekly Cough Severity VAS score was ≤-30 mm (or a ≥30 mm reduction from baseline); participants considered non-responders otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with ≤ -30 mm change from baseline in Cough Severity VAS at Week 12 (≥30 mm reduction from baseline) was reported for all treatment study arms. |
| Secondary | Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | Baseline, Week 12 | The LCQ assesses the impact of chronic cough on health-related quality of life. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of individual item score within the domain divided by the number of items in the domain. LCQ total score is the sum of the three domain scores and ranges from 3-21; with a higher score corresponding to a better health status. A participant was considered a responder if the change from baseline in LCQ total score was ≥1.3-points (increase from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≥1.3-point change from baseline in LCQ total score at Week 12 was reported for all treatment study arms. |
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 Objective Coughs Per Hour (Week 12/Baseline) | Baseline, Week 12 | All randomized participants in the analysis model who had taken at least 1 dose of study intervention and provided at least 1 baseline and at least 1 Week 12 24-hour cough observation during the treatment period were analyzed. | ratio | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up | Up to approximately 54 weeks | All randomized participants who received at least 1 dose of study intervention during the 52-week treatment period were analyzed. Per protocol, participants who continued in the optional Off-Treatment observational period were not included in the primary safety analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Treatment Due to AEs | Up to approximately 52 weeks | All randomized participants who received at least 1 dose of study intervention during the 52-week treatment period were analyzed. Per protocol, participants who continued in the optional Off-Treatment observational period were not included in the primary safety analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline) | Baseline, Week 12 | All randomized participants in the analysis model who had taken at least 1 dose of study intervention and provided at least 1 baseline and at least 1 Week 12 awake cough observation during the treatment period were analyzed. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at Week 12 | Baseline, Week 12 | All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available 24-hour cough data at baseline and at least one available post-baseline measurement were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants (Model-Based) With a ≤ -1.3-point Change From Baseline in Mean Weekly Cough Severity Diary (CSD) Total Score at Week 12 | Baseline, Week 12 | All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available CSD data at baseline and at least one available post-baseline measurement were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at Week 12 | Baseline, Week 12 | All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available CSD data at baseline and at least one available post-baseline measurement were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 12 | Baseline, Week 12 | All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available Cough Severity VAS data at baseline and at least one available post-baseline measurement were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | Baseline, Week 12 | All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available LCQ data at baseline and at least one available post-baseline measurement were analyzed. | 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 Objective Coughs Per Hour (Week 12/Baseline) | Placebo | 0.47 | 95% Confidence Interval 0.41 to 0.54 | ratio | |
| Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline) | Gefapixant 15 mg BID | 0.48 | 95% Confidence Interval 0.41 to 0.55 | ratio | |
| Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline) | Gefapixant 45 mg BID | 0.38 | 95% Confidence Interval 0.33 to 0.44 | ratio | |
| Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up | Placebo | 184 | Participants | ||
| Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up | Gefapixant 15 mg BID | 186 | Participants | ||
| Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up | Gefapixant 45 mg BID | 208 | Participants | ||
| Number of Participants Who Discontinued Treatment Due to AEs | Placebo | 14 | Participants | ||
| Number of Participants Who Discontinued Treatment Due to AEs | Gefapixant 15 mg BID | 15 | Participants | ||
| Number of Participants Who Discontinued Treatment Due to AEs | Gefapixant 45 mg BID | 51 | Participants | ||
| Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline) | Placebo | 0.46 | 95% Confidence Interval 0.40 to 0.53 | ratio |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 52-Week Treatment Period | STARTED | Placebo | 244 | |
| 52-Week Treatment Period | STARTED | Gefapixant 15 mg BID | 244 | |
| 52-Week Treatment Period | STARTED | Gefapixant 45 mg BID | 244 | |
| 52-Week Treatment Period | Treated | Placebo | 243 | |
| 52-Week Treatment Period | Treated | Gefapixant 15 mg BID | 244 | |
| 52-Week Treatment Period | Treated | Gefapixant 45 mg BID | 243 | |
| 52-Week Treatment Period | COMPLETED | Placebo | 199 | |
| 52-Week Treatment Period | COMPLETED | Gefapixant 15 mg BID | 200 | |
| 52-Week Treatment Period | COMPLETED | Gefapixant 45 mg BID | 184 | |
| 52-Week Treatment Period | NOT COMPLETED | Placebo | 45 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events414
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 | 14 | 243 | 19 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 15 mg BID | 15 | 244 | 19 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 45 mg BID | 12 | 243 | 23 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo: Off-Tx | 0 | 10 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 15 mg BID: Off-Tx | 0 | 18 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 45 mg BID: Off-Tx | 0 | 13 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 6 | 243 | 7 |
| other | Dry mouth | Gastrointestinal disorders | Gefapixant 15 mg BID | 7 | 244 | 7 |
| other | Dry mouth | Gastrointestinal disorders | Gefapixant 45 mg BID | 13 | 243 | 13 |
| other | Dry mouth | Gastrointestinal disorders | Placebo: Off-Tx | 0 | 10 | 0 |
1 to 10 of 414Source ClinicalTrials.gov
See all 414 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 2 | 244 |
| Total, all-cause mortality | Gefapixant 15 mg BID | 1 | 244 |
| Total, all-cause mortality | Gefapixant 45 mg BID | 0 | 244 |
| Total, all-cause mortality | Placebo: Off-Tx | 0 | 10 |
| Total, all-cause mortality | Gefapixant 15 mg BID: Off-Tx | 0 | 18 |
| Total, all-cause mortality | Gefapixant 45 mg BID: Off-Tx | 0 | 13 |
| Total, other adverse events | Placebo | 129 | 243 |
| Total, other adverse events | Gefapixant 15 mg BID | 140 | 244 |
| Total, other adverse events | Gefapixant 45 mg BID | 179 | 243 |
| Total, other adverse events | Placebo: Off-Tx | 0 | 10 |
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/NCT03449134
GET https://conductscience.org/api/trials/v1/NCT03449134/results?page=2