Trial · NCT02502097
A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016)
NCT02502097, Phase 2, Completed, Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2021-05-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016). Trials, record NCT02502097. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02502097
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016)
- NCT number
- NCT02502097
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Idiopathic Pulmonary Fibrosis, Cough
- Interventions
- Gefapixant, Placebo
- First posted
- 2015-07-20
- Last updated
- 2021-05-26
- Results first posted
- 2021-05-26
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2) | Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0 (baseline), and after administration of the study drug on Day 7 and Day 14 in Periods 1 and 2. The cough frequency is the coughs/hour over each 24-hour period. Awake objective cough frequency was analyzed using Mixed Effect Model for Repeated Measures (MMRM) to evaluate the results of the 2-period cross-over study. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the end of the dosing period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency. |
| Primary | Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2) | Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0 (baseline), and after administration of the study drug on Day 7 and Day 14 in Periods 1 and 2. The cough frequency is the coughs/hour over each 24-hour period. Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the end of the dosing period. |
| Primary | Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2) | Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0 (baseline), and after administration of the study drug on Day 7 and Day 14 in Periods 1 and 2. The cough frequency is the coughs/hour over each 24-hour period. Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the end of the dosing period. A negative value indicates a decrease in cough frequency. |
| Primary | Percent Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2) | Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Percent change from baseline in awake objective cough frequency (0-6 hours after the morning dose) was reported at each dosing interval. Percent change in awake cough frequency = 100 X (post treatment cough frequency - baseline cough frequency) divided by the baseline cough frequency. A negative value indicates a decrease in cough frequency. |
| Secondary | MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 1) | Baseline (Day 0), Day 7, and Day 14 (Period 1) | Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Change from Baseline in awake cough frequency = post-treatment awake cough frequency - Baseline awake cough frequency. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the end of the dosing period. Awake objective cough frequency for Period 1 was analyzed for using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures. |
| Secondary | MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 2) | Baseline (Day 0), Day 7, and Day 14 (Period 2) | Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. Change from baseline in awake cough frequency = post-treatment awake cough frequency - Baseline awake cough frequency. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency. Baseline cough frequency was derived from the cough monitoring performed at the beginning of each treatment period while the post-treatment cough frequency was derived from the cough monitoring performed at the at the end of the dosing period. Awake objective cough frequency for Period 2 was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures. |
| Secondary | Responder Analysis of Awake Cough Frequency at Day 7 (Periods 1 & 2 Combined) | Day 7 (Period 1 and Period 2) | Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. The number of participants that met responder criteria for ≥70%, ≥50%, ≥30%, and ≥20% change (reduction) from baseline levels in 24-hour awake cough frequency was reported (Period 1 and Period 2 combined) at Day 7. |
| Secondary | Responder Analysis of Awake Cough Frequency at Day 14 (Periods 1 & 2 Combined) | Day 14 (Period 1 and Period 2) | Awake objective cough frequency was defined as the total number of cough events during the monitoring period the participant was awake divided by the total duration for the monitoring period the participant was awake. The number of participants that met responder criteria for ≥70%, ≥50%, ≥30%, and ≥20% change (reduction) from baseline levels in 24-hour awake cough frequency was reported (Period 1 and Period 2 combined) at Day 14. |
| Secondary | MMRM Analysis of Change From Baseline 24-hour Objective Cough Frequency (Periods 1 & 2 Combined) | Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2) | 24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency. 24-hour objective cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures. |
| Secondary | MMRM Analysis of Change From Baseline in 24-hour Objective Cough Frequency (Period 1) | Baseline (Day 0), Day 7, and Day 14 (Period 1) | 24-hour objective cough frequency = total number of coughs during the monitoring period divided by the total duration for the monitoring period. A negative value indicates a decrease in cough frequency. A positive value indicates an increase in cough frequency. 24-hour objective cough frequency for Period 1 was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2) | The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis. | Coughs/hour | LEAST_SQUARES_MEAN |
| PRIMARY | Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2) | The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis. | Coughs/hour | MEAN |
| PRIMARY | Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2) | The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis. | Coughs/hour | MEAN |
| PRIMARY | Percent Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2) | The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis. | Percent change | MEAN |
| SECONDARY | MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 1) | Baseline (Day 0), Day 7, and Day 14 (Period 1) | The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis. | Coughs/hour | LEAST_SQUARES_MEAN |
| SECONDARY | MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 2) | Baseline (Day 0), Day 7, and Day 14 (Period 2) | The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis. | Coughs/hour | LEAST_SQUARES_MEAN |
| SECONDARY | Responder Analysis of Awake Cough Frequency at Day 7 (Periods 1 & 2 Combined) | Day 7 (Period 1 and Period 2) | The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Responder Analysis of Awake Cough Frequency at Day 14 (Periods 1 & 2 Combined) | Day 14 (Period 1 and Period 2) | The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | MMRM Analysis of Change From Baseline 24-hour Objective Cough Frequency (Periods 1 & 2 Combined) | Baseline (Day 0), Day 7, and Day 14 (Period 1 and Period 2) | The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis. | Coughs/hour | LEAST_SQUARES_MEAN |
| SECONDARY | MMRM Analysis of Change From Baseline in 24-hour Objective Cough Frequency (Period 1) | Baseline (Day 0), Day 7, and Day 14 (Period 1) | The analysis population includes all randomized participants who had a baseline and at least 1 post-baseline frequency values, were enrolled into the study under protocol amendment 3, and had otherwise complied with the protocol without any major protocol deviations. Participants enrolled prior to protocol amendment 3 were not included in the efficacy analysis. | Coughs/hour | LEAST_SQUARES_MEAN |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Gefapixant | Day 7 | -9.1 | Standard Error 2.7 | Coughs/hour |
| Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Placebo | Day 7 | -6.6 | Standard Error 2.7 | Coughs/hour |
| Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Gefapixant | Day 14 | -6.6 | Standard Error 4.5 | Coughs/hour |
| Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Placebo | Day 14 | -5.8 | Standard Error 4.4 | Coughs/hour |
| Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Gefapixant | Baseline | 46.2 | Standard Deviation 43.06 | Coughs/hour |
| Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Placebo | Baseline | 48.0 | Standard Deviation 55.17 | Coughs/hour |
| Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Gefapixant | Day 7 | 37.1 | Standard Deviation 46.52 | Coughs/hour |
| Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Placebo | Day 7 | 41.8 | Standard Deviation 50.11 | Coughs/hour |
| Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Gefapixant | Day 14 | 39.4 | Standard Deviation 57.67 | Coughs/hour |
| Awake Objective Cough Frequency (Periods 1 & 2 Combined) | Placebo | Day 14 | 41.9 | Standard Deviation 44.37 | Coughs/hour |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Gefapixant>Placebo Pre-Amendment 3 | 4 | |
| Period 1 | STARTED | Placebo>Gefapixant Pre-Amendment 3 | 3 | |
| Period 1 | STARTED | Gefapixant>Placebo Post-Amendment 3 | 22 | |
| Period 1 | STARTED | Placebo>Gefapixant Post-Amendment 3 | 22 | |
| Period 1 | COMPLETED | Gefapixant>Placebo Pre-Amendment 3 | 4 | |
| Period 1 | COMPLETED | Placebo>Gefapixant Pre-Amendment 3 | 3 | |
| Period 1 | COMPLETED | Gefapixant>Placebo Post-Amendment 3 | 21 | |
| Period 1 | COMPLETED | Placebo>Gefapixant Post-Amendment 3 | 22 | |
| Period 1 | NOT COMPLETED | Gefapixant>Placebo Pre-Amendment 3 | 0 | |
| Period 1 | NOT COMPLETED | Placebo>Gefapixant Pre-Amendment 3 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events69
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 | 2 | 45 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 50 mg | 3 | 47 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Gefapixant 150 mg | 0 | 4 | 0 |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Gefapixant 50 mg | 4 | 47 | 5 |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Gefapixant 150 mg | 0 | 4 | 0 |
| other | Paraesthesia oral | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
| other | Paraesthesia oral | Gastrointestinal disorders | Gefapixant 50 mg | 4 | 47 | 6 |
| other | Paraesthesia oral | Gastrointestinal disorders | Gefapixant 150 mg | 0 | 4 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Gefapixant 50 mg | ||
| Total, all-cause mortality | Gefapixant 150 mg | ||
| Total, other adverse events | Placebo | 12 | 45 |
| Total, other adverse events | Gefapixant 50 mg | 39 | 47 |
| Total, other adverse events | Gefapixant 150 mg | 3 | 4 |
| Total, serious adverse events | Placebo | 3 | 45 |
| Total, serious adverse events | Gefapixant 50 mg | 3 | 47 |
| Total, serious adverse events | Gefapixant 150 mg | 1 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34152585 | 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 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.
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