NCT02612610

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

A 12-Week Study to Assess the Efficacy and Safety of AF 219 in Subjects With Refractory Chronic Cough

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Gefapixant	Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.
DRUG	Placebo (for gefapixant)

Timeline

• Start date: 2015-12-15
• Primary completion: 2016-10-31
• Completion: 2016-11-04
• First posted: 2015-11-24
• Last updated: 2020-06-30
• Results posted: 2018-02-14

Regulatory

• FDA-regulated drug study