A Phase 3 interventional study of Placebo and Gefapixant 15 mg BID in Chronic Cough, sponsored by Merck Sharp & Dohme LLC. Completed at 171 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-02.
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 has the largest 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 1,317 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 primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.
This study will have a main 24-week treatment period and a 28-week extension period of treatment (total treatment period of 52 weeks). Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 12-week, Off-treatment Durability Study Period. Any assessments conducted in the observational period will be exploratory.
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.
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.
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 will receive a matching placebo tablet BID during the 24-week main study period and the 28-week extension period.
Drug: Placebo
Participants will receive a gefapixant 15 mg tablet BID and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and the 28-week extension period.
Drug: Placebo · Drug: Gefapixant 15 mg BID
Participants will receive a gefapixant 45 mg tablet BID and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and during the 28-week extension period.
Drug: Placebo · Drug: Gefapixant 45 mg BID
Placebo tablet administered orally BID
Gefapixant 15 mg tablet administered orally BID
Also known as: MK-7264
Gefapixant 45 mg tablet administered orally BID
Also known as: MK-7264
Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline
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.
Time frame: Baseline, Week 24
Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up
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.
Time frame: Up to 54 Weeks
Number of Participants Who Discontinued a Study Drug Due to an AE
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.
Time frame: Up to 52 weeks
Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
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.
Time frame: Baseline, Week 24
Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at 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.
Time frame: Baseline, Week 24
Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at 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% change (≥30% reduction) in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 24 (≥30% reduction from baseline) is presented.
Time frame: Baseline, Week 24
Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at 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 change from baseline in CSD at Week 24 (or ≥1.3 point reduction from baseline) is reported.
Time frame: Baseline, Week 24
Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at 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 change from baseline in CSD at Week 24 (or ≥2.7 point reduction from baseline) is reported.
Time frame: Baseline, Week 24
Percentage of Participants With a ≤-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at 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 ≤-30 mm change from baseline in cough severity VAS score at Week 24 is reported.
Time frame: Baseline, Week 24
| Milestone | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Started | 436 | 442 | 439 |
| Completed | 382 | 368 | 355 |
| Not completed | 54 | 74 | 84 |
| Withdrew: Death | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 6 | 2 | 5 |
| Withdrew: Other | 0 | 1 | 2 |
| Withdrew: Physician decision | 1 | 0 | 3 |
| Withdrew: Screen failure | 1 | 2 | 0 |
| Withdrew: Withdrawal by subject | 46 | 68 | 74 |
| Milestone | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Started | 48 | 37 | 37 |
| Completed | 47 | 36 | 37 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Other | 0 | 1 | 0 |
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.
| Ratio | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline | 0.43 (0.39 to 0.48) | 0.43 (0.38 to 0.47) | 0.37 (0.33 to 0.41) |
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.
| Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up | 349 | 373 | 399 |
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.
| Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Number of Participants Who Discontinued a Study Drug Due to an AE | 25 | 40 | 100 |
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.
| Ratio | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline | 0.42 (0.38 to 0.47) | 0.41 (0.37 to 0.46) | 0.36 (0.32 to 0.40) |
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.
| Percentage of Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg |
|---|---|---|---|
| Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24 | 70.1 | 75.9 | 76.8 |
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% change (≥30% reduction) in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 24 (≥30% reduction from baseline) is presented.
| Percentage of Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID |
|---|---|---|---|
| Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24 | 66.9 | 67.4 | 72.9 |
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 change from baseline in CSD at Week 24 (or ≥1.3 point reduction from baseline) is reported.
| Percentage of Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg |
|---|---|---|---|
| Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24 | 69.1 | 74.8 | 77.1 |
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 change from baseline in CSD at Week 24 (or ≥2.7 point reduction from baseline) is reported.
| Percentage of Participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg |
|---|---|---|---|
| Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24 | 41.0 | 46.6 | 55.2 |
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 ≤-30 mm change from baseline in cough severity VAS score at Week 24 is reported.
| Percentage of participants | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg |
|---|---|---|---|
| Percentage of Participants With a ≤-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24 | 40.9 | 51.4 | 53.3 |
Collected over On-Treatment Period: 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 | 0/433 (0%) | 25/432 (5.8%) | 248/432 (57.4%) |
| Gefapixant 15 mg BID | 1/444 (0.2%) | 24/442 (5.4%) | 290/442 (65.6%) |
| Gefapixant 45 mg BID | 0/440 (0%) | 25/440 (5.7%) | 359/440 (81.6%) |
| Placebo: Off Tx | 0/48 (0%) | 0/48 (0%) | 6/48 (12.5%) |
| Gefapixant 15 mg BID: Off Tx | 0/37 (0%) | 0/37 (0%) | 3/37 (8.1%) |
| Gefapixant 45 mg BID: Off Tx | 0/37 (0%) | 1/37 (2.7%) | 1/37 (2.7%) |
| 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 |
|---|---|---|---|---|---|---|
| ArrhythmiaCardiac disorders | 0/432 | 0/442 | 0/440 | 0/48 | 0/37 | 1/37 |
| PneumoniaInfections and infestations | 0/432 | 3/442 | 1/440 | 0/48 | 0/37 | 0/37 |
| GastritisGastrointestinal disorders | 2/432 | 0/442 | 0/440 | 0/48 | 0/37 | 0/37 |
| UrosepsisInfections and infestations | 2/432 | 0/442 | 0/440 | 0/48 | 0/37 | 0/37 |
| Laryngeal stenosisRespiratory, thoracic and mediastinal disorders | 2/432 | 0/442 | 0/440 | 0/48 | 0/37 | 0/37 |
| InfluenzaInfections and infestations | 0/432 | 2/442 | 0/440 | 0/48 | 0/37 | 0/37 |
| Myocardial infarctionCardiac disorders | 1/432 | 0/442 | 0/440 | 0/48 | 0/37 | 0/37 |
| PyrexiaGeneral disorders | 1/432 | 0/442 | 0/440 | 0/48 | 0/37 | 0/37 |
| BronchitisInfections and infestations | 1/432 | 0/442 | 0/440 | 0/48 | 0/37 | 0/37 |
| COVID-19 pneumoniaInfections and infestations | 1/432 | 0/442 | 0/440 | 0/48 | 0/37 | 0/37 |
| 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 | 28/432 | 56/442 | 193/440 | 0/48 | 0/37 | 0/37 |
| NasopharyngitisInfections and infestations | 70/432 | 93/442 | 70/440 | 2/48 | 0/37 | 0/37 |
| HeadacheNervous system disorders | 67/432 | 74/442 | 70/440 | 1/48 | 0/37 | 0/37 |
| AgeusiaNervous system disorders | 6/432 | 13/442 | 67/440 | 0/48 | 0/37 | 0/37 |
| HypogeusiaNervous system disorders | 3/432 | 17/442 | 60/440 | 0/48 | 0/37 | 0/37 |
| NauseaGastrointestinal disorders | 32/432 | 26/442 | 47/440 | 0/48 | 0/37 | 0/37 |
| Upper respiratory tract infectionInfections and infestations | 26/432 | 38/442 | 30/440 | 0/48 | 0/37 | 0/37 |
| Taste disorderNervous system disorders | 1/432 | 8/442 | 37/440 | 0/48 | 0/37 | 0/37 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 11/432 | 13/442 | 19/440 | 1/48 | 3/37 | 1/37 |
| InfluenzaInfections and infestations | 35/432 | 29/442 | 24/440 | 0/48 | 0/37 | 0/37 |
| Age, Continuous(Years) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| Mean | 58.4 ± 12.5 | 58.4 ± 11.3 | 57.8 ± 12.4 | 58.2 ± 12.1 |
| Sex: Female, Male(Participants) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| Female | 326 | 331 | 329 | 986 |
| Male | 110 | 111 | 110 | 331 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| Hispanic or Latino | 85 | 93 | 89 | 267 |
| Not Hispanic or Latino | 348 | 347 | 344 | 1039 |
| Unknown or Not Reported | 3 | 2 | 6 | 11 |
| Race (NIH/OMB)(Participants) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 20 | 28 | 24 | 72 |
| Asian | 15 | 14 | 15 | 44 |
| Native Hawaiian or Other Pacific Islander | 4 | 2 | 3 | 9 |
| Black or African American | 5 | 9 | 14 | 28 |
| White | 356 | 358 | 346 | 1060 |
| More than one race | 36 | 31 | 37 | 104 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Baseline 24-Hour Coughs Per Hour(Coughs/Hour) | Placebo | Gefapixant 15 mg BID | Gefapixant 45 mg BID | Total |
|---|---|---|---|---|
| Mean | 27.45 ± 24.44 | 26.82 ± 21.25 | 26.84 ± 27.04 | 27.04 ± 24.35 |
Showing the first 100 of 171 sites across 20 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 Aug 2020, 29 months.
Results were first posted in Sep 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 Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gefapixant