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A 12-Week Study in Participants With Refractory Chronic Cough (MK-7264-012)

NCT02612610 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2020-06-30

Study results available
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Summary

This study is designed to evaluate the efficacy of three dose regimens of gefapixant (\[MK-7264\] 7.5 mg, 20 mg, and 50 mg) relative to placebo in reducing awake objective cough frequency. The primary hypothesis for this trial is that at least one dose regimen of gefapixant is superior to placebo with respect to the mean change from baseline in awake cough frequency (on the log scale).

Conditions

  • Refractory Chronic Cough

Interventions

DRUG

Gefapixant

Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.

DRUG

Placebo (for gefapixant)

Sponsors & Collaborators

  • Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Afferent Pharmaceuticals Clinical Research · Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-15
Primary Completion
2016-10-31
Completion
2016-11-04
FDA Drug
Yes

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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 NCT02612610 on ClinicalTrials.gov