MK-7264 phase 3 study in adult participants with chronic cough (PN030)
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants with Chronic Cough (PN030)
IRAS ID
241788
Contact name
Surinder Birring
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2017-003559-49
Duration of Study in the UK
3 years, 1 months, 0 days
Research summary
Cough is one of the most common presenting symptoms for patients. Current therapies for cough have limited effectiveness and undesirable side effects.
P2X3 purinergic receptors are expressed in the airways and, when activated by binding Adenosine Triphosphate (ATP), cause sensitisation of the airways resulting in a cough. The drug to be tested in this study is MK-7264 which is a P2X3 receptor antagonist. MK-7264 can bind to P2X3 receptors, preventing ATP binding and thereby prevent the cough response from occurring.
This trial aims to evaluate the efficacy and safety of MK-7264 in the treatment of refractory chronic (persistent, long term) or unexplained chronic cough.
In this study, adult participants with chronic cough will receive treatment twice daily with either MK-7265 45mg, MK-7264 15mg or placebo (dummy drug) in a 1:1:1 ratio, over a 52-week period. Cough frequency will then be measured using a cough-counting device to compare frequency in participants treated with MK-7264 45mg, MK-7264 15 mg or placebo at 7 timepoints during the 24-week Main Study Period. During the 28-week Extension Study Period, participants will record and rate their coughs via electronic patient reported outcomes (ePROs).
Approximately 1290 participants will be enrolled into this study which will last approximately 37 months. Each participant will be in the study for approximately 56 weeks. The study will take place at 16 private and NHS sites in the UK and is funded by Merck Sharp & Dohme Limited.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0711
Date of REC Opinion
20 Jun 2018
REC opinion
Further Information Favourable Opinion