Trial · NCT04525885
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension
NCT04525885, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2023-10-02
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)-China Extension. Trials, record NCT04525885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04525885
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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)-China Extension
- NCT number
- NCT04525885
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 161 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chronic Cough
- Interventions
- Gefapixant 45 mg twice daily (BID), Gefapixant 15 mg BID, Placebo, Gefapixant 45 mg BID
- First posted
- 2020-08-25
- Last updated
- 2024-01-12
- Results first posted
- 2023-10-02
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, 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 | Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | Up to 54 weeks | Assessment of participants who have at least one AE during the main study period (24 weeks), the treatment extension period (28 weeks), and during 2 weeks of follow-up by telephone. |
| Primary | Percentage of Participants Who Discontinued Treatment Due to an AE | Up 52 weeks | Assessment of participants who stop study treatment due to an AE during the main study period (24 weeks) or the treatment extension period (28 weeks). |
| 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 Increase 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% Reduction 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% reduction in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≥30% reduction 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 Reduction 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 reduction from baseline in CSD at Week 24 is reported. |
| Secondary | Percentage of Participants With ≥2.7-point Reduction 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 reduction from baseline in CSD at Week 24 is reported. |
| Secondary | Percentage of Participants With a ≥30 mm Reduction 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 ≥30mm reduction 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, Week 24 | All China participants randomized to the gefapixant 45 mg BID or placebo groups who received at least 1 dose of study intervention. Participants needed to have baseline and at least 1 post-baseline measurement. Efficacy evaluation of the gefapixant 15 mg BID group was removed from the study objectives of the China cohort per protocol amendment 5. Participants were analyzed in the group as randomized. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | Up to 54 weeks | All randomized China participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants Who Discontinued Treatment Due to an AE | Up 52 weeks | All randomized China participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline | Baseline, Week 24 | All China participants randomized to the gefapixant 45 mg BID or placebo groups who received at least 1 dose of study intervention. Efficacy evaluation of the gefapixant 15 mg BID group was removed from the study objectives of the China cohort per protocol amendment 5. Participants needed to have awake 24-hour cough data at baseline and at least 1 post-baseline measurement. Participants were analyzed in the group as randomized. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With a ≥1.3-point Increase From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24 | Baseline, Week 24 | All China participants randomized to the gefapixant 45 mg BID or placebo groups who received at least 1 dose of study intervention. Efficacy evaluation of the gefapixant 15 mg BID group was removed from the study objectives of the China cohort per protocol amendment 5. Participants needed to have LCQ data at baseline and at least 1 post-baseline measurement. Participants were analyzed in the group as randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Coughs Per Hour at Week 24 | Baseline, Week 24 | All China participants randomized to the gefapixant 45 mg BID or placebo groups who received at least 1 dose of study intervention. Efficacy evaluation of the gefapixant 15 mg BID group was removed from the study objectives of the China cohort per protocol amendment 5. Participants needed to have 24-hour cough data at baseline and at least 1 post-baseline measurement. Participants were analyzed in the group as randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥1.3-point Reduction From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24 | Baseline, Week 24 | All China participants randomized to the gefapixant 45 mg BID or placebo groups who received at least 1 dose of study intervention. Efficacy evaluation of the gefapixant 15 mg BID group was removed from the study objectives of the China cohort per protocol amendment 5. Participants needed to have CSD data at baseline and at least 1 post-baseline measurement. Participants were analyzed in the group as randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥2.7-point Reduction From Baseline of Mean Weekly CSD Total Score at Week 24 | Baseline, Week 24 | All China participants randomized to the gefapixant 45 mg BID or placebo groups who received at least 1 dose of study intervention. Efficacy evaluation of the gefapixant 15 mg BID group was removed from the study objectives of the China cohort per protocol amendment 5. Participants needed to have CSD data at baseline and at least 1 post-baseline measurement. Participants were analyzed in the group as randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≥30 mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24 | Baseline, Week 24 | All China participants randomized to the gefapixant 45 mg BID or placebo groups who received at least 1 dose of study intervention. Efficacy evaluation of the gefapixant 15 mg BID group was removed from the study objectives of the China cohort per protocol amendment 5. Participants needed to have CSD data at baseline and at least 1 post-baseline measurement. Participants were analyzed in the group as randomized. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
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 | Placebo | 0.47 | 95% Confidence Interval 0.35 to 0.64 | Ratio | |
| Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24 | Gefapixant 45 mg Twice Daily (BID) | 0.51 | 95% Confidence Interval 0.37 to 0.71 | Ratio | |
| Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | Placebo | 54 | Participants | ||
| Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | Gefapixant 15 mg BID | 20 | Participants | ||
| Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | Gefapixant 45 mg Twice Daily (BID) | 58 | Participants | ||
| Percentage of Participants Who Discontinued Treatment Due to an AE | Gefapixant 45 mg Twice Daily (BID) | 0 | Participants | ||
| Percentage of Participants Who Discontinued Treatment Due to an AE | Gefapixant 15 mg BID | 1 | Participants | ||
| Percentage of Participants Who Discontinued Treatment Due to an AE | Placebo | 5 | Participants | ||
| Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline | Placebo | 0.46 | 95% Confidence Interval 0.33 to 0.62 | Ratio | |
| Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline | Gefapixant 45 mg Twice Daily (BID) | 0.51 | 95% Confidence Interval 0.37 to 0.70 | Ratio |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 68 | |
| Overall Study | STARTED | Gefapixant 15 mg BID | 27 | |
| Overall Study | STARTED | Gefapixant 45 mg Twice Daily (BID) | 66 | |
| Overall Study | Number Treated | Placebo | 67 | |
| Overall Study | Number Treated | Gefapixant 15 mg BID | 27 | |
| Overall Study | Number Treated | Gefapixant 45 mg Twice Daily (BID) | 66 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | COMPLETED | Gefapixant 15 mg BID | 21 | |
| Overall Study | COMPLETED | Gefapixant 45 mg Twice Daily (BID) | 45 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events96
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 | Chronic gastritis | Gastrointestinal disorders | Placebo | 1 | 67 | 1 |
| other | Chronic gastritis | Gastrointestinal disorders | MK-7264 15 mg BID | 0 | 27 | 0 |
| other | Chronic gastritis | Gastrointestinal disorders | MK-7264 45 mg BID | 4 | 66 | 5 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 3 | 67 | 3 |
| other | Dry mouth | Gastrointestinal disorders | MK-7264 15 mg BID | 0 | 27 | 0 |
| other | Dry mouth | Gastrointestinal disorders | MK-7264 45 mg BID | 4 | 66 | 4 |
| other | Gastritis | Gastrointestinal disorders | Placebo | 0 | 67 | 0 |
| other | Gastritis | Gastrointestinal disorders | MK-7264 15 mg BID | 3 | 27 | 3 |
| other | Gastritis | Gastrointestinal disorders | MK-7264 45 mg BID | 2 | 66 | 2 |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Placebo | 1 | 67 | 1 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 68 |
| Total, all-cause mortality | MK-7264 15 mg BID | 0 | 27 |
| Total, all-cause mortality | MK-7264 45 mg BID | 0 | 66 |
| Total, other adverse events | Placebo | 42 | 67 |
| Total, other adverse events | MK-7264 15 mg BID | 17 | 27 |
| Total, other adverse events | MK-7264 45 mg BID | 53 | 66 |
| Total, serious adverse events | Placebo | 4 | 67 |
| Total, serious adverse events | MK-7264 15 mg BID | 4 | 27 |
| Total, serious adverse events | MK-7264 45 mg BID | 2 | 66 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04525885
GET https://conductscience.org/api/trials/v1/NCT04525885/events?page=2