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A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)

NCT03449134 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 732

Last updated 2021-06-16

Study results available
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Summary

The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.

Conditions

  • Chronic Cough

Interventions

DRUG

Placebo

Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.

DRUG

Gefapixant

Gefapixant 15 mg or 45 mg tablet administered orally BID during the 12-week main study period and during the 40-week extension period, according to randomization.

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
2018-03-14
Primary Completion
2020-06-05
Completion
2020-08-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Czechia
  • Denmark
  • France
  • Hungary
  • Israel
  • Japan
  • Peru
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • 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 NCT03449134 on ClinicalTrials.gov