| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04193202 | Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043) | PHASE3 | COMPLETED | 419 | — | — | May 21, 2020 | Nov 3, 2021 | May 16, 2023 | 91 | United States, Canada +10 |
| NCT04193176 | Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042) | PHASE3 | COMPLETED | 376 | — | — | May 10, 2020 | Sep 2, 2022 | Nov 5, 2024 | 90 | United States, Argentina +10 |
| NCT03696108 | A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038) | PHASE3 | COMPLETED | 175 | — | — | Oct 31, 2018 | Oct 7, 2020 | Nov 1, 2021 | 61 | Japan |
| NCT03449147 | A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030) | PHASE3 | COMPLETED | 1,317 | — | — | Mar 15, 2018 | Oct 30, 2020 | Sep 2, 2021 | 171 | United States, Australia +18 |
| NCT03449134 | A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027) | PHASE3 | COMPLETED | 732 | — | — | Mar 14, 2018 | Aug 17, 2020 | Jun 16, 2021 | 156 | United States, Argentina +15 |
| NCT03482713 | Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033) | PHASE2 | COMPLETED | 23 | — | — | Mar 16, 2018 | Jun 7, 2018 | Oct 17, 2019 | 16 | Japan |
| NCT01432730 | A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006) | PHASE2 | COMPLETED | 24 | — | — | Sep 22, 2011 | Feb 21, 2013 | Nov 24, 2020 | - | — |
Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated.
Cough-induced SUI episodes were assessed using an event-driven electronic Incontinence Diary where the participant recorded the main cause of each urinary incontinence episode as coughing, another stress reason, or other cause. Episodes of incontinence were recorded for the week before baseline and treatment visit. Average daily cough induced SUI episodes were calculated as (sum of daily cough-induced SUI episodes in a week)/number of days recorded. The percent change from baseline in the average daily cough-induced SUI episodes to Week 12 are presented.
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.
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.
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.
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.
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.
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.
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.
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.
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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.
| Arm | Type | Description |
|---|---|---|
| Gefapixant | EXPERIMENTAL | Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks. |
| Gefapixant 15 mg BID | EXPERIMENTAL | Participants will receive gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg twice daily (BID) during the study period (52 weeks). |
| Gefapixant 45 mg BID | EXPERIMENTAL | Participants will receive gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the study period (52 weeks). |
| Gefapixant 45 mg | EXPERIMENTAL | Participants will receive a gefapixant 45 mg film-coated tablet BID for 28 days. |
| Gefapixant 600 mg>Placebo | EXPERIMENTAL | Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks followed by a 2-week washout period and then placebo to gefapixant, BID, taken orally for 2 weeks. |
| Placebo>Gefapixant 600 mg | EXPERIMENTAL | Placebo to gefapixant BID, taken orally for 2 weeks followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks. |
| Name | Type | Description |
|---|---|---|
| Gefapixant | DRUG | Administered twice daily as an oral tablet of 45 mg |
| Placebo | DRUG | Administered twice daily as a placebo oral tablet matching gefapixant |
| Gefapixant 15 mg BID | DRUG | Gefapixant 15 mg tablet administered orally BID |
| Gefapixant 45 mg BID | DRUG | Gefapixant 45 mg tablet administered orally BID |
| Gefapixant 45 mg | DRUG | Gefapixant 45 mg (film-coated tablet) to be administered orally BID |
Inclusion Criteria: * Chest radiograph or CT thorax (within 1 year of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease, in the opinion of the pr...