A Phase 3 interventional study of Gefapixant and Placebo in Chronic Cough, sponsored by Merck Sharp & Dohme LLC. Completed at 90 sites in 12 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of gefapixant, in improving symptoms of cough-induced stress urinary incontinence (SUI) in adult female participants with refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in reducing the frequency of cough-induced SUI episodes over 12 weeks.
346 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's enrollment of 376 is above the median of 70 across 263 interventional studies indexed under Cough.
Browse Cough studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Drug: Gefapixant
Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Drug: Placebo
Administered twice daily as an oral tablet of 45 mg
Also known as: MK-7264
Administered twice daily as a placebo oral tablet matching gefapixant
Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12
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.
Time frame: Baseline and week 12
Percentage of Participants With Adverse Events
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented.
Time frame: Up to ~16 weeks
Percentage of Participants Who Discontinued Study Intervention Due to AEs
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study intervention due to an adverse event are presented.
Time frame: Up to ~14 weeks
Of the 376 randomized participants, 375 participants received treatment.
| Milestone | Placebo | Gefapixant |
|---|---|---|
| Started | 190 | 186 |
| Treated | 190 | 185 |
| Completed | 184 | 176 |
| Not completed | 6 | 10 |
| Withdrew: Withdrawal by subject | 6 | 10 |
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.
| Percent Change | Placebo | Gefapixant |
|---|---|---|
| Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12 | -41.09 (-46.74 to -35.45) | -52.78 (-58.44 to -47.09) |
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented.
| Percentage of participants | Placebo | Gefapixant |
|---|---|---|
| Percentage of Participants With Adverse Events | 37.4 | 69.7 |
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study intervention due to an adverse event are presented.
| Percentage of participants | Placebo | Gefapixant |
|---|---|---|
| Percentage of Participants Who Discontinued Study Intervention Due to AEs | 1.1 | 7.0 |
Collected over All deaths and adverse events: up to 16 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/190 (0%) | 2/190 (1.1%) | 12/190 (6.3%) |
| Gefapixant | 0/186 (0%) | 3/185 (1.6%) | 104/185 (56.2%) |
| Event | Placebo | Gefapixant |
|---|---|---|
| Rectal fissureGastrointestinal disorders | 0/190 | 1/185 |
| Cholecystitis chronicHepatobiliary disorders | 0/190 | 1/185 |
| Ankle fractureInjury, poisoning and procedural complications | 0/190 | 1/185 |
| COVID-19Infections and infestations | 1/190 | 0/185 |
| Bowen's diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/190 | 0/185 |
| Event | Placebo | Gefapixant |
|---|---|---|
| DysgeusiaNervous system disorders | 4/190 | 57/185 |
| AgeusiaNervous system disorders | 1/190 | 35/185 |
| HypogeusiaNervous system disorders | 0/190 | 14/185 |
| HeadacheNervous system disorders | 5/190 | 13/185 |
| NauseaGastrointestinal disorders | 2/190 | 10/185 |
| Age, Continuous(Years) | Placebo | Gefapixant | Total |
|---|---|---|---|
| Mean | 56.6 ± 11.3 | 56.2 ± 11.5 | 56.4 ± 11.4 |
| Sex: Female, Male(Participants) | Placebo | Gefapixant | Total |
|---|---|---|---|
| Female | 190 | 186 | 376 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Gefapixant | Total |
|---|---|---|---|
| Hispanic or Latino | 79 | 73 | 152 |
| Not Hispanic or Latino | 111 | 113 | 224 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Gefapixant | Total |
|---|---|---|---|
| American Indian or Alaska Native | 18 | 16 | 34 |
| Asian | 3 | 6 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 3 |
| White | 143 | 137 | 280 |
| More than one race | 26 | 24 | 50 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Weight(kilograms) | Placebo | Gefapixant | Total |
|---|---|---|---|
| Mean | 75.6 ± 13.1 | 75.9 ± 13.3 | 75.8 ± 13.2 |
| Height(centimeters) | Placebo | Gefapixant | Total |
|---|---|---|---|
| Mean | 159.6 ± 6.9 | 159.8 ± 7.0 | 159.7 ± 7.0 |
| Body mass index(kg/m^2) | Placebo | Gefapixant | Total |
|---|---|---|---|
| Mean | 29.7 ± 4.4 | 29.7 ± 4.8 | 29.7 ± 4.6 |
| Region(Participants) | Placebo | Gefapixant | Total |
|---|---|---|---|
| North America | 11 | 9 | 20 |
| Europe | 102 | 102 | 204 |
| Asia Pacific | 3 | 3 | 6 |
| Other | 74 | 72 | 146 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Oct 2024. 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.
Merck Sharp & Dohme LLC