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COMPLETED Phase 3

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

NCT04193176 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 376 participants
Start Date 2020-05-10
Est. Completion 2022-09-02
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04193176

The ClinicalTrials.gov registry entry for NCT04193176 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 376 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04193176 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, North Carolina, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04193176?

The interventions under investigation include: Placebo (DRUG), Gefapixant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04193176?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial