Trial · NCT01432730
A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006)
NCT01432730, Phase 2, Completed, Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2020-11-02
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006). Trials, record NCT01432730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01432730
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006)
- NCT number
- NCT01432730
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Chronic Cough
- Interventions
- Gefapixant, Placebo
- First posted
- 2011-09-13
- Last updated
- 2020-11-24
- Other registries' IDs
- eudract:2010-024283-18
- Results first posted
- 2020-11-02
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Daytime Objective Cough Frequency | Baseline (Day 0) and Day 14 of each study period | Daytime Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participants is awake. 24-hour sound recordings were collected using a digital recording device. Change from baseline in awake cough frequency = (post-treatment awake cough frequency - baseline awake cough frequency). A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. |
| Secondary | Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS) | Baseline (Day 0) and Day 15 of each study period | Cough Severity VAS: scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 100mm with 0 representing no cough and 100 the most severe cough. Change from baseline in daytime cough severity = (post-treatment daytime cough severity - baseline daytime cough severity). A negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity. |
| Secondary | Change From Baseline in Nighttime Objective Cough Frequency | Baseline (Day 0) and Day 14 of each study period | Nighttime Objective Cough Frequency = Total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep. 24 hour sound recording were collected with a digital recording device. Change from baseline in nighttime cough frequency = (post-treatment nighttime cough frequency - baseline nighttime cough frequency). A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. |
| Secondary | Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS) | Baseline (Day 0) and Day 15 of each study period | Cough Severity VAS: scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 100mm with 0 representing no cough and 100 the most severe cough. Change from baseline in nighttime cough severity = (post-treatment nighttime cough severity - baseline nighttime cough severity). A negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity. |
| Secondary | Change From Baseline of 24-hour Objective Cough Frequency | 24 hours at Baseline (Day 0) and Day 14 of each study period | Total (0-24 hours) Objective Cough Frequency = Total number of cough events during the monitoring period divided by the total duration (in hours, i.e., 24 hours mostly) for the monitoring period. 24-hour sound recordings were collected using a digital recording device. A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. |
| Secondary | Global Rating of Change Score for Cough Frequency | Day 15 of each study period | At the end of each study period, participants were asked to complete the global rating of change scale questionnaire. The participants were asked to record whether their cough frequency was "worse", "about the same", or "better". If better or worse, the participants were then asked "by how much" with a 7-category rating scale. Therefore, a 15-point ordered scale was used (1=minimum, a very great deal better to 15=maximum, a very great deal worse with a score of 8=indicating no change). |
| Secondary | Global Rating of Change Score for Cough Severity | Day 15 of each study period | At the end of each study period, participants were asked to complete the global rating of change scale questionnaire. The participants were asked to record whether their cough severity was "worse", "about the same", or "better". If better or worse, the participants were then asked "by how much" with a 7-category rating scale. Therefore, a 15-point ordered scale was used (1=minimum, a very great deal better to 15=maximum, a very great deal worse with a score of 8=indicating no change). |
| Secondary | Change From Baseline in Cough-specific Quality of Life Questionnaire (CQLQ) | Baseline (Day 0) and Day 15 of each study period | The CQLQ Questionnaire included 28 items that described negative aspects of quality of life specific to chronic cough. Subscales include: Physical complaints, Psychosocial issues, Functional abilities, Emotional wellbeing, Extreme physical complaints, and Personal safety fears. Participants indicated their degree of agreement with each statement on a 4 point scale (1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree). CQLQ scores (28 for least impact, 112 for highest impact) used a mixed effect model with terms for treatment sequence, participant within sequence, treatment, and period. Change from baseline in CQLQ scores = (posttreatment CQLQ scores - baseline CQLQ scores). A negative result indicates a decrease in CQLQ scores (lowest cough impact on health-related quality of life), while a positive result indicates an increase in CQLQ scores (highest cough impact on health-related quality of life). |
| Secondary | Change From Baseline in Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale | Baseline (Day 0) and Day 15 of each study period | UtCQ is determined through the use of a 100mm visual analogue scale (VAS) (ranging between 0 for "no urge to cough" and 100 for "severe urge to cough"). Change from baseline in UtCQ scores = (post-treatment UtCQ scores - baseline UtCQ scores). A negative result indicates a decrease in UtCQ scores (lowest impact), while a positive result indicates an increase in UtCQ scores (highest impact). |
| Other | Baseline Daytime Cough Frequency | Baseline (Day 0) of each study period | Daytime Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participants is awake. 24-hour sound recordings were collected using a digital recording device. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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 Daytime Objective Cough Frequency | Baseline (Day 0) and Day 14 of each study period | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Coughs/hour | LOG_MEAN |
| SECONDARY | Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS) | Baseline (Day 0) and Day 15 of each study period | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Nighttime Objective Cough Frequency | Baseline (Day 0) and Day 14 of each study period | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Coughs/hour | LOG_MEAN |
| SECONDARY | Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS) | Baseline (Day 0) and Day 15 of each study period | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline of 24-hour Objective Cough Frequency | 24 hours at Baseline (Day 0) and Day 14 of each study period | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Coughs/hour | LOG_MEAN |
| SECONDARY | Global Rating of Change Score for Cough Frequency | Day 15 of each study period | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Global Rating of Change Score for Cough Severity | Day 15 of each study period | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Cough-specific Quality of Life Questionnaire (CQLQ) | Baseline (Day 0) and Day 15 of each study period | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale | Baseline (Day 0) and Day 15 of each study period | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Baseline Daytime Cough Frequency | Baseline (Day 0) of each study period | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for daytime cough frequency. | Coughs/hour | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
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 Daytime Objective Cough Frequency | Gefapixant 600 mg | -0.5365 | Standard Error 0.1718 | Coughs/hour | |
| Change From Baseline in Daytime Objective Cough Frequency | Placebo | 0.0523 | Standard Error 0.0462 | Coughs/hour | |
| Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS) | Gefapixant 600 mg | -21.5 | Standard Deviation 35.65 | Score on a scale | |
| Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS) | Placebo | -0.7 | Standard Deviation 19.01 | Score on a scale | |
| Change From Baseline in Nighttime Objective Cough Frequency | Gefapixant 600 mg | -0.3452 | Standard Error 0.2314 | Coughs/hour | |
| Change From Baseline in Nighttime Objective Cough Frequency | Placebo | 0.0690 | Standard Error 0.1767 | Coughs/hour | |
| Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS) | Gefapixant 600 mg | -16.1 | Standard Deviation 27.71 | Score on a scale | |
| Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS) | Placebo | -3.7 | Standard Deviation 22.05 | Score on a scale | |
| Change From Baseline of 24-hour Objective Cough Frequency | Gefapixant 600 mg | -0.5562 | Standard Error 0.1795 | Coughs/hour | |
| Change From Baseline of 24-hour Objective Cough Frequency | Placebo | 0.0298 | Standard Error 0.0459 | Coughs/hour |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Gefapixant 600 mg>Placebo | 12 | |
| Period 1 | STARTED | Placebo>Gefapixant 600mg | 12 | |
| Period 1 | COMPLETED | Gefapixant 600 mg>Placebo | 10 | |
| Period 1 | COMPLETED | Placebo>Gefapixant 600mg | 12 | |
| Period 1 | NOT COMPLETED | Gefapixant 600 mg>Placebo | 2 | |
| Period 1 | NOT COMPLETED | Placebo>Gefapixant 600mg | 0 | |
| Period 2 | STARTED | Gefapixant 600 mg>Placebo | 10 | |
| Period 2 | STARTED | Placebo>Gefapixant 600mg | 12 | |
| Period 2 | COMPLETED | Gefapixant 600 mg>Placebo | 10 | |
| Period 2 | COMPLETED | Placebo>Gefapixant 600mg | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
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 | Vision blurred | Eye disorders | Gefapixant 600 mg | 2 | 24 | 2 |
| other | Vision blurred | Eye disorders | Placebo | 0 | 22 | 0 |
| other | Constipation | Gastrointestinal disorders | Gefapixant 600 mg | 2 | 24 | 3 |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 22 | 0 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Gefapixant 600 mg | 2 | 24 | 2 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo | 0 | 22 | 0 |
| other | Glossodynia | Gastrointestinal disorders | Gefapixant 600 mg | 2 | 24 | 2 |
| other | Glossodynia | Gastrointestinal disorders | Placebo | 0 | 22 | 0 |
| other | Nausea | Gastrointestinal disorders | Gefapixant 600 mg | 9 | 24 | 9 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 22 | 1 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gefapixant 600 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Gefapixant 600 mg | 24 | 24 |
| Total, other adverse events | Placebo | 5 | 22 |
| Total, serious adverse events | Gefapixant 600 mg | 0 | 24 |
| Total, serious adverse events | Placebo | 0 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25467586 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Gefapixant 600 mg vs Placebo: serious adverse events |
Source 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/NCT01432730
GET https://conductscience.org/api/trials/v1/NCT01432730/results?page=2