A Phase 3 interventional study of Placebo and Gefapixant in Chronic Cough, sponsored by Merck Sharp & Dohme LLC. Completed at 156 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-16.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
Among 15 studies testing gefapixant in Chronic Cough — 2 open to participants now, 2 under way, none of them phase 3. Gefapixant · Chronic Cough.
Among the 15 studies testing gefapixant in Chronic Cough, this one is the 2nd largest by enrollment, is one of 4 that started in 2018, is one of 6 in phase 3, and was the 7th registered.
142 studies on the registry are indexed under Chronic Cough; 39 are open to participants now.
Browse Chronic Cough studies →2 of the 15 studies testing gefapixant in Chronic Cough are open now, in 2 countries. Recruiting first, the newest first:
Nagoya City University · Sites in Japan
Stuart Mazzone · Sites in Australia
By country, each count listing its studies:
Gefapixant: first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 30 Chronic Cough studies recruiting now, 10 (33%) set no upper age limit and 11 (37%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 4 started in 2018.
This study's enrollment of 732 is above the median of 60 across 104 interventional studies indexed under Chronic Cough.
Median enrollment 63 across the 15 interventional studies. Of the 13 that completed or were terminated, 13 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 15 have an industry lead sponsor. The 4 most frequent:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Merck Sharp & Dohme LLC has 7 studies filed under Chronic Cough — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing gefapixant in Chronic Cough, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.
The study will include a screening period to determine participant inclusion, and the Baseline visit will include 24 hours of objective measurement of cough. The study will consist of two treatment periods, a main 12-week treatment period and a 40-week extension period (52 weeks total treatment), followed by a 14-day telephone follow-up period.
Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 3-month, Off-treatment Durability Study Period, which extends the Estimated Study Completion Date. The Off-treatment Durability Study Period will explore the impact of withdrawing gefapixant in refractory or unexplained chronic cough participants who have been treated for 1 year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.
Drug: Placebo
Participants receive a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.
Drug: Placebo · Drug: Gefapixant
Participants receive a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.
Drug: Placebo · Drug: Gefapixant
Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.
Gefapixant 15 mg or 45 mg tablet administered orally BID during the 12-week main study period and during the 40-week extension period, according to randomization.
Also known as: MK-7264
Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline)
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.
Time frame: Baseline, Week 12
Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up
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.
Time frame: Up to approximately 54 weeks
Number of Participants Who Discontinued Treatment Due to AEs
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.
Time frame: Up to approximately 52 weeks
Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline)
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.
Time frame: Baseline, Week 12
Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at 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.
Time frame: Baseline, Week 12
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
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.
Time frame: Baseline, Week 12
Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at 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.
Time frame: Baseline, Week 12
Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at 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.
Time frame: Baseline, Week 12
Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at 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.
Time frame: Baseline, Week 12
| Milestone | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Started | 244 | 244 | 244 |
| Treated | 243 | 244 | 243 |
| Completed | 199 | 200 | 184 |
| Not completed | 45 | 44 | 60 |
| Withdrew: Death | 2 | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 |
| Withdrew: Physician decision | 2 | 3 | 3 |
| Withdrew: Screen failure | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 37 | 39 | 55 |
| Withdrew: Site closure | 1 | 0 | 0 |
| Milestone | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Started | 10 | 18 | 13 |
| Completed | 10 | 18 | 13 |
| Not completed | 0 | 0 | 0 |
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.
| ratio | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline) | 0.47 (0.41 to 0.54) | 0.48 (0.41 to 0.55) | 0.38 (0.33 to 0.44) |
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.
| Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up | 184 | 186 | 208 |
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.
| Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Number of Participants Who Discontinued Treatment Due to AEs | 14 | 15 | 51 |
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.
| ratio | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline) | 0.46 (0.40 to 0.53) | 0.47 (0.41 to 0.55) | 0.38 (0.33 to 0.44) |
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.
| Percentage of Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at Week 12 | 65.9 | 66.2 | 69.9 |
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.
| Percentage of Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| 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 | 52.4 | 62.1 | 60.5 |
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.
| Percentage of Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at Week 12 | 28.6 | 37.9 | 40.1 |
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.
| Percentage of Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 12 | 31.3 | 36.7 | 41.2 |
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.
| Percentage of Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | 61.3 | 68.8 | 67.3 |
Collected over On-Treatment Period (plus 2-week telephone follow-up): Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 2/244 (0.8%) | 14/243 (5.8%) | 129/243 (53.1%) |
| Gefapixant 15 mg BID | 1/244 (0.4%) | 17/244 (7%) | 140/244 (57.4%) |
| Gefapixant 45 mg BID | 0/244 (0%) | 13/243 (5.3%) | 179/243 (73.7%) |
| Placebo: Off-Tx | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Gefapixant 15 mg BID: Off-Tx | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Gefapixant 45 mg BID: Off-Tx | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| Event | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Placebo: Off-Tx | Gefapixant 15 mg BID: Off-Tx | Gefapixant 45 mg BID: Off-Tx |
|---|---|---|---|---|---|---|
| Abdominal adhesionsGastrointestinal disorders | 0/243 | 0/244 | 1/243 | 0/10 | 0/18 | 0/13 |
| Abdominal wall cystGastrointestinal disorders | 1/243 | 0/244 | 0/243 | 0/10 | 0/18 | 0/13 |
| Duodenal ulcer haemorrhageGastrointestinal disorders | 0/243 | 0/244 | 1/243 | 0/10 | 0/18 | 0/13 |
| NauseaGastrointestinal disorders | 1/243 | 0/244 | 0/243 | 0/10 | 0/18 | 0/13 |
| VomitingGastrointestinal disorders | 1/243 | 0/244 | 0/243 | 0/10 | 0/18 | 0/13 |
| Accidental deathGeneral disorders | 1/243 | 0/244 | 0/243 | 0/10 | 0/18 | 0/13 |
| DeathGeneral disorders | 1/243 | 0/244 | 0/243 | 0/10 | 0/18 | 0/13 |
| Papilloma viral infectionInfections and infestations | 1/243 | 0/244 | 0/243 | 0/10 | 0/18 | 0/13 |
| TonsillitisInfections and infestations | 0/243 | 0/244 | 1/243 | 0/10 | 0/18 | 0/13 |
| Urinary tract infectionInfections and infestations | 1/243 | 0/244 | 0/243 | 0/10 | 0/18 | 0/13 |
| Event | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Placebo: Off-Tx | Gefapixant 15 mg BID: Off-Tx | Gefapixant 45 mg BID: Off-Tx |
|---|---|---|---|---|---|---|
| DysgeusiaNervous system disorders | 8/243 | 22/244 | 88/243 | 0/10 | 0/18 | 0/13 |
| NasopharyngitisInfections and infestations | 51/243 | 47/244 | 50/243 | 0/10 | 1/18 | 0/13 |
| HeadacheNervous system disorders | 31/243 | 34/244 | 29/243 | 0/10 | 0/18 | 0/13 |
| AgeusiaNervous system disorders | 0/243 | 3/244 | 33/243 | 0/10 | 0/18 | 0/13 |
| Taste disorderNervous system disorders | 2/243 | 2/244 | 24/243 | 0/10 | 0/18 | 0/13 |
| Back painMusculoskeletal and connective tissue disorders | 19/243 | 14/244 | 20/243 | 0/10 | 0/18 | 0/13 |
| BronchitisInfections and infestations | 11/243 | 20/244 | 11/243 | 0/10 | 0/18 | 0/13 |
| Respiratory tract infectionInfections and infestations | 1/243 | 2/244 | 0/243 | 0/10 | 0/18 | 1/13 |
| Upper respiratory tract infectionInfections and infestations | 9/243 | 18/244 | 13/243 | 0/10 | 0/18 | 0/13 |
| NauseaGastrointestinal disorders | 13/243 | 8/244 | 17/243 | 0/10 | 0/18 | 0/13 |
| Age, Continuous(Years) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| Mean | 57.9 ± 13.1 | 59.6 ± 11.7 | 59.5 ± 13.1 | 59.0 ± 12.6 |
| Sex: Female, Male(Participants) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| Female | 182 | 181 | 181 | 544 |
| Male | 62 | 63 | 63 | 188 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| Hispanic or Latino | 33 | 35 | 33 | 101 |
| Not Hispanic or Latino | 204 | 205 | 208 | 617 |
| Unknown or Not Reported | 7 | 4 | 3 | 14 |
| Race (NIH/OMB)(Participants) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 7 | 6 | 8 | 21 |
| Asian | 35 | 35 | 34 | 104 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 4 | 11 |
| White | 190 | 195 | 187 | 572 |
| More than one race | 8 | 5 | 11 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Geographic Region(Participants) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| Asia Pacific | 35 | 34 | 34 | 103 |
| Europe | 121 | 123 | 122 | 366 |
| North America | 56 | 55 | 56 | 167 |
| Others | 31 | 32 | 32 | 95 |
| Missing | 1 | 0 | 0 | 1 |
| Baseline 24-hour Coughs per Hour(coughs/hour) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| Mean | 38.07 ± 79.42 | 26.79 ± 21.13 | 28.53 ± 37.14 | 31.10 ± 52.04 |
Showing the first 100 of 156 sites across 17 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Mar 2018 to primary completion in Jun 2020, 26 months.
Results were first posted in Jun 2021, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Gefapixant