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NCT04193176 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
A Phase 3 study of Chronic Cough, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 376
- Enrollment target
- 20
- Study locations
NCT04193176: Completed Phase 3 study of Chronic Cough, sponsored by Merck Sharp & Dohme.
NCT04193176 is a Phase 3 study of Chronic Cough that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 376 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04193176, a Phase 3 study of Chronic Cough, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 376 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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 averag
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Gefapixant
Study Locations (20)
Florida
- Health Awareness, Inc. ( Site 0038) - Jupiter
- Well Pharma Medical Research, Corp. ( Site 0040) - Miami
- Lenus Research & Medical Group Llc ( Site 0007) - Sweetwater
- Florida Pulmonary Research Institute, LLC ( Site 0008) - Winter Park
North Carolina
- American Health Research ( Site 0027) - Charlotte
- Clinical Research of Gastonia ( Site 0016) - Gastonia
- PMG Research of Wilmington ( Site 0004) - Wilmington
Virginia
- TPMG Clinical Research ( Site 0025) - Newport News
- Tidewater Physician Multispecialty Group, PC ( Site 0028) - Williamsburg
California
- Center for Clinical Trials, LLC ( Site 0021) - Paramount
Maine
- Paul A. Shapero, MD ( Site 0037) - Bangor
Maryland
- Chesapeake Clinical Research, Inc ( Site 0022) - White Marsh
Missouri
- University of Missouri ENT & Allergy Center ( Site 0010) - Columbia
Nevada
- Alliance for Multispecialty Research, LLC ( Site 0035) - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2020-05-10 |
| Est. Completion | 2022-09-02 |
| Phase | Phase 3 |
What the finished NCT04193176 record still lists
NCT04193176 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Chronic Cough appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04193176 names 20 study sites across 14 states, led by Florida, North Carolina, Virginia.
Frequently Asked Questions
What is clinical trial NCT04193176 about?
NCT04193176 is a clinical study titled "Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)". 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 redu...
What is the current status of trial NCT04193176?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 376 participants. The study started on 2020-05-10. Estimated completion is 2022-09-02.
What conditions does trial NCT04193176 study?
This clinical trial studies the following conditions: Chronic Cough.
What interventions are being tested in trial NCT04193176?
The interventions under investigation include: Placebo (DRUG), Gefapixant (DRUG).
Who is sponsoring clinical trial NCT04193176?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04193176 being conducted?
This trial has 20 study locations across California, Florida, Maine, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Cough
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04193176's enrollment target sits among peer trials
376 988th of 2000 higher than 1,013 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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