Trial · NCT04193176

Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)

NCT04193176, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2023-09-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042). Trials, record NCT04193176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04193176

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
NCT number: NCT04193176
Status: Completed
Phases: Phase 3
Enrollment: 376 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Chronic Cough
Interventions: Gefapixant, Placebo
First posted: 2019-12-10
Last updated: 2024-11-05
Other registries' IDs: eudract:2019-002321-29
Results first posted: 2023-09-22

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12	Baseline and 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.
Secondary	Percentage of Participants With Adverse Events	Up to ~16 weeks	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.
Secondary	Percentage of Participants Who Discontinued Study Intervention Due to AEs	Up to ~14 weeks	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12	Baseline and week 12	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.	Percent Change	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Adverse Events	Up to ~16 weeks	All randomized participants who received at least one dose of study intervention.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Discontinued Study Intervention Due to AEs	Up to ~14 weeks	All randomized participants who received at least one dose of study intervention.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12	Placebo	-41.09	95% Confidence Interval -46.74 to -35.45	Percent Change
Percent Change From Baseline in Average Daily Cough-induced Stress Urinary Incontinence (SUI) Episodes at Week 12	Gefapixant	-52.78	95% Confidence Interval -58.44 to -47.09	Percent Change
Percentage of Participants With Adverse Events	Placebo	37.4		Percentage of participants
Percentage of Participants With Adverse Events	Gefapixant	69.7		Percentage of participants
Percentage of Participants Who Discontinued Study Intervention Due to AEs	Placebo	1.1		Percentage of participants
Percentage of Participants Who Discontinued Study Intervention Due to AEs	Gefapixant	7.0		Percentage of participants

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	190
Overall Study	STARTED	Gefapixant	186
Overall Study	Treated	Placebo	190
Overall Study	Treated	Gefapixant	185
Overall Study	COMPLETED	Placebo	184
Overall Study	COMPLETED	Gefapixant	176
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Gefapixant	10

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Placebo	2	190	2
other	Nausea	Gastrointestinal disorders	Gefapixant	10	185	10
other	Ageusia	Nervous system disorders	Placebo	1	190	1
other	Ageusia	Nervous system disorders	Gefapixant	35	185	36
other	Dysgeusia	Nervous system disorders	Placebo	4	190	4
other	Dysgeusia	Nervous system disorders	Gefapixant	57	185	59
other	Headache	Nervous system disorders	Placebo	5	190	5
other	Headache	Nervous system disorders	Gefapixant	13	185	14
other	Hypogeusia	Nervous system disorders	Placebo	0	190	0
other	Hypogeusia	Nervous system disorders	Gefapixant	14	185	14

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	190
Total, all-cause mortality	Gefapixant	0	186
Total, other adverse events	Placebo	12	190
Total, other adverse events	Gefapixant	104	185
Total, serious adverse events	Placebo	2	190
Total, serious adverse events	Gefapixant	3	185

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39222649	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gefapixant vs Placebo: deaths from any cause	Trial comparisons
Gefapixant vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04193176

GET https://conductscience.org/api/trials/v1/NCT04193176/registered

API reference For AI assistants