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A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

NCT03449147 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1317

Last updated 2021-09-02

Study results available
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Summary

The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

Conditions

  • Chronic Cough

Interventions

DRUG

Placebo

Placebo tablet administered orally BID

DRUG

Gefapixant 15 mg BID

Gefapixant 15 mg tablet administered orally BID

DRUG

Gefapixant 45 mg BID

Gefapixant 45 mg tablet administered orally BID

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2020-08-20
Completion
2020-10-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Colombia
  • Czechia
  • Denmark
  • Germany
  • Guatemala
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • New Zealand
  • Peru
  • Poland
  • South Africa
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03449147 on ClinicalTrials.gov