At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 253 enrolled
Drug / intervention
Gefapixant +1 moredrug
Likely dose
Gefapixant 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-Week Study to Assess the Efficacy and Safety of AF 219 in Subjects With Refractory Chronic Cough
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Nov 24, 2015·Updated Jun 30, 2020
In Brief
A Phase 2 clinical trial evaluating Gefapixant and Placebo (for gefapixant) for Refractory Chronic Cough. Completed, enrolled 253 participants.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Chronic Cough
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartDec 2015
Primary CompletionOct 2016
Study CompletionNov 2016
TodayJul 2026
First PostedNov 24, 2015
Enrollment StartDec 15, 2015
Primary CompletionOct 31, 2016
Study CompletionNov 4, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.6 years ago
Interventions
Gefapixantdrug
Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.
Placebo (for gefapixant)drug