drugset / Trial / NCT02349425
A Dose Escalation Study of Gefapixant (AF-219/MK-7264) in Refractory Chronic Cough (MK-7264-010)
Phase 2
Completed
59 enrolled
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
RandomizedCrossoverQuadruple-blindTreatment
Summary
A randomized, double-blind, placebo-controlled, crossover, dose escalation study to assess the efficacy and tolerability of gefapixant (AF-219; MK-7264) in participants with refractory chronic cough.
Timeline
- Start
- 2015-03-09
- Primary completion
- 2016-02-01
- Completion
- 2016-02-09
Publications
- Results LATE-BREAKING ABSTRACT: Tackling the burden of chronic cough: A dose escalation study of AF-219 Jaclyn Smith, Michael Kitt, Mandel Sher, Peter Butera, Anthony Ford European Respiratory Journal 2016 48: OA1976; DOI: 10.1183/13993003.congress-2016.OA1976
- Results Smith JA, Kitt MM, Butera P, Smith SA, Li Y, Xu ZJ, Holt K, Sen S, Sher MR, Ford AP. Gefapixant in two randomised dose-escalation studies in chronic cough. Eur Respir J. 2020 Mar 20;55(3):1901615. doi: 10.1183/13993003.01615-2019. Print 2020 Mar.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gefapixant | Small molecule | 7.5 mg | Oral |
| Subject | Gefapixant | Small molecule | 15 mg | Oral |
| Subject | Gefapixant | Small molecule | 30 mg | Oral |
| Subject | Gefapixant | Small molecule | 50 mg | Oral |
| Subject | Gefapixant | Small molecule | 100 mg | Oral |
| Subject | Gefapixant | Small molecule | 150 mg | Oral |
| Subject | Gefapixant | Small molecule | 200 mg | Oral |