Trial Outcomes & Findings for Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042) (NCT NCT04193176)

NCT ID: NCT04193176

Last Updated: 2024-11-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

376 participants

Primary outcome timeframe

Baseline and week 12

Results posted on

2024-11-05

Participant Flow

Of the 376 randomized participants, 375 participants received treatment.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo administered as an oral tablet twice daily for 12 weeks.	Gefapixant Participants received gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Overall Study STARTED	190	186
Overall Study Treated	190	185
Overall Study COMPLETED	184	176
Overall Study NOT COMPLETED	6	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo administered as an oral tablet twice daily for 12 weeks.	Gefapixant Participants received gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Overall Study Withdrawal by Subject	6	10

Baseline Characteristics

Participants with data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=190 Participants Participants received placebo administered as an oral tablet twice daily for 12 weeks.	Gefapixant n=186 Participants Participants received gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.	Total n=376 Participants Total of all reporting groups
Age, Continuous	56.6 Years STANDARD_DEVIATION 11.3 • n=190 Participants	56.2 Years STANDARD_DEVIATION 11.5 • n=186 Participants	56.4 Years STANDARD_DEVIATION 11.4 • n=376 Participants
Sex: Female, Male Female	190 Participants n=190 Participants	186 Participants n=186 Participants	376 Participants n=376 Participants
Sex: Female, Male Male	0 Participants n=190 Participants	0 Participants n=186 Participants	0 Participants n=376 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	79 Participants n=190 Participants	73 Participants n=186 Participants	152 Participants n=376 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=190 Participants	113 Participants n=186 Participants	224 Participants n=376 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=190 Participants	0 Participants n=186 Participants	0 Participants n=376 Participants
Race (NIH/OMB) American Indian or Alaska Native	18 Participants n=190 Participants	16 Participants n=186 Participants	34 Participants n=376 Participants
Race (NIH/OMB) Asian	3 Participants n=190 Participants	6 Participants n=186 Participants	9 Participants n=376 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=190 Participants	0 Participants n=186 Participants	0 Participants n=376 Participants
Race (NIH/OMB) Black or African American	0 Participants n=190 Participants	3 Participants n=186 Participants	3 Participants n=376 Participants
Race (NIH/OMB) White	143 Participants n=190 Participants	137 Participants n=186 Participants	280 Participants n=376 Participants
Race (NIH/OMB) More than one race	26 Participants n=190 Participants	24 Participants n=186 Participants	50 Participants n=376 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=190 Participants	0 Participants n=186 Participants	0 Participants n=376 Participants
Weight	75.6 kilograms STANDARD_DEVIATION 13.1 • n=190 Participants	75.9 kilograms STANDARD_DEVIATION 13.3 • n=186 Participants	75.8 kilograms STANDARD_DEVIATION 13.2 • n=376 Participants
Height	159.6 centimeters STANDARD_DEVIATION 6.9 • n=190 Participants	159.8 centimeters STANDARD_DEVIATION 7.0 • n=186 Participants	159.7 centimeters STANDARD_DEVIATION 7.0 • n=376 Participants
Body mass index	29.7 kg/m^2 STANDARD_DEVIATION 4.4 • n=190 Participants	29.7 kg/m^2 STANDARD_DEVIATION 4.8 • n=186 Participants	29.7 kg/m^2 STANDARD_DEVIATION 4.6 • n=376 Participants
Region North America	11 Participants n=190 Participants	9 Participants n=186 Participants	20 Participants n=376 Participants
Region Europe	102 Participants n=190 Participants	102 Participants n=186 Participants	204 Participants n=376 Participants
Region Asia Pacific	3 Participants n=190 Participants	3 Participants n=186 Participants	6 Participants n=376 Participants
Region Other	74 Participants n=190 Participants	72 Participants n=186 Participants	146 Participants n=376 Participants
Primary cough diagnosis Refractory Chronic Cough	149 Participants n=190 Participants	141 Participants n=186 Participants	290 Participants n=376 Participants
Primary cough diagnosis Unexplained Chronic Cough	41 Participants n=190 Participants	45 Participants n=186 Participants	86 Participants n=376 Participants
Duration of Chronic Cough	5.1 Years STANDARD_DEVIATION 6.6 • n=143 Participants • Participants with data	5.3 Years STANDARD_DEVIATION 6.5 • n=155 Participants • Participants with data	5.2 Years STANDARD_DEVIATION 6.6 • n=298 Participants • Participants with data
Baseline Mean Weekly Cough Severity in Visual Analog Scale (VAS) in mm	69.5 VAS (mm) STANDARD_DEVIATION 15.6 • n=190 Participants • Participants with data	69.3 VAS (mm) STANDARD_DEVIATION 15.8 • n=185 Participants • Participants with data	69.4 VAS (mm) STANDARD_DEVIATION 15.7 • n=375 Participants • Participants with data
Duration of Stress Urinary Incontinence (SUI)	53.8 Months STANDARD_DEVIATION 80.8 • n=190 Participants	43.4 Months STANDARD_DEVIATION 58.3 • n=186 Participants	48.7 Months STANDARD_DEVIATION 70.7 • n=376 Participants
Baseline Mean Daily Cough-Induced Stress Urinary Incontinence Episodes, 7-day Average	4.7 Number of episodes STANDARD_DEVIATION 4.1 • n=189 Participants • Participants who had data	4.7 Number of episodes STANDARD_DEVIATION 3.0 • n=185 Participants • Participants who had data	4.7 Number of episodes STANDARD_DEVIATION 3.6 • n=374 Participants • Participants who had data

PRIMARY outcome

Timeframe: Baseline and week 12

Population: All randomized participants who received at least 1 dose of study intervention and had incontinence frequency of at least 4 days in the 7-day period prior to the visit at Week 12.

Outcome measures

Outcome measures
Measure	Placebo n=185 Participants Participants received placebo administered as an oral tablet twice daily for 12 weeks.	Gefapixant n=183 Participants Participants received gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12	-41.09 Percent Change Interval -46.74 to -35.45	-52.78 Percent Change Interval -58.44 to -47.09

SECONDARY outcome

Timeframe: Up to ~16 weeks

Population: All randomized participants who received at least one dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Placebo n=190 Participants Participants received placebo administered as an oral tablet twice daily for 12 weeks.	Gefapixant n=185 Participants Participants received gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Percentage of Participants With Adverse Events	37.4 Percentage of participants	69.7 Percentage of participants

SECONDARY outcome

Timeframe: Up to ~14 weeks

Population: All randomized participants who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	Placebo n=190 Participants Participants received placebo administered as an oral tablet twice daily for 12 weeks.	Gefapixant n=185 Participants Participants received gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Percentage of Participants Who Discontinued Study Intervention Due to AEs	1.1 Percentage of participants	7.0 Percentage of participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Gefapixant

Serious events: 3 serious events

Other events: 104 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=190 participants at risk Participants received placebo administered as an oral tablet twice daily for 12 weeks.	Gefapixant n=185 participants at risk Participants received gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Gastrointestinal disorders Rectal fissure	0.00% 0/190 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.	0.54% 1/185 • Number of events 1 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/190 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.	0.54% 1/185 • Number of events 1 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.
Infections and infestations COVID-19	0.53% 1/190 • Number of events 1 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.	0.00% 0/185 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/190 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.	0.54% 1/185 • Number of events 1 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.53% 1/190 • Number of events 1 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.	0.00% 0/185 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.

Other adverse events

Other adverse events
Measure	Placebo n=190 participants at risk Participants received placebo administered as an oral tablet twice daily for 12 weeks.	Gefapixant n=185 participants at risk Participants received gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Gastrointestinal disorders Nausea	1.1% 2/190 • Number of events 2 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.	5.4% 10/185 • Number of events 10 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.
Nervous system disorders Ageusia	0.53% 1/190 • Number of events 1 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.	18.9% 35/185 • Number of events 36 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.
Nervous system disorders Dysgeusia	2.1% 4/190 • Number of events 4 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.	30.8% 57/185 • Number of events 59 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.
Nervous system disorders Headache	2.6% 5/190 • Number of events 5 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.	7.0% 13/185 • Number of events 14 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.
Nervous system disorders Hypogeusia	0.00% 0/190 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.	7.6% 14/185 • Number of events 14 • All deaths and adverse events: up to 16 Weeks Every participant is counted a single time for each applicable serious adverse event. A system organ class appears on this report only if one or more specific serious adverse events in that system organ class occurred.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
Publication restrictions are in place

Restriction type: OTHER