Trials / Completed
CompletedNCT04193202
Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 419 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration \>8 weeks after onset of cough symptoms) for \<12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gefapixant | Administered twice daily as an oral tablet of 45 mg |
| DRUG | Placebo | Administered twice daily as a placebo oral tablet matching gefapixant |
Timeline
- Start date
- 2020-05-21
- Primary completion
- 2021-10-19
- Completion
- 2021-11-03
- First posted
- 2019-12-10
- Last updated
- 2023-05-16
- Results posted
- 2022-10-14
Locations
91 sites across 12 countries: United States, Canada, Colombia, Germany, Guatemala, Peru, Poland, Russia, South Korea, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04193202. Inclusion in this directory is not an endorsement.