Principal Investigator: Prof Lorcan McGarvey
Name of the Study: A Phase 2b, multicenter, randomized, double-blind,
placebo-controlled, parallel-group, dose-selection study of S-600918 in patients with refractory chronic cough
Short name: Shionogi 1812VA323
Why is this important? The prevalence of chronic cough has been estimated as affecting 11-13% of the population and there have been no FDA approvals for a novel pharmaceutical agent to treat cough in over 50 years. Chronic cough can seriously impair quality of life as it has physical (exhaustion, sleep deprivation, urinary incontinence, vomiting, headache, rib fracture) social (interference with lifestyle and leisure, embarrassment of coughing in public, social exclusion) and psychosocial (depression, frustration, anxiety) consequences.
What is the Research question/aim? A clinical drug trial is investigating drug S-600918.The aim of the study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo.
What the Study involves: A total of approximately 372 patients with refractory chronic cough are planned to be treated in Japan, Europe, and the United States. This study will involve participants attending 7 visits taking place over an 8-10 week period. Following the screening period & randomization, patients will take study drug orally once daily for 28 days. Patients will then be followed for 14 days after the last dose of study drug. Participants will also be asked to wear a cough monitor for 24 hours multiple times during the trial to monitor any changes.
Who can take part in the Study? The study will enroll women and men aged 18-80 years old who have unexplained, refractory chronic cough for at least one year. Participant’s medical history, medication use, cough severity, contraception use and smoking status will need to be reviewed to confirm if they are eligible to take part.
Principal Investigator: Lorcan McGarvey Principal Investigator
Contact phone number: 02895041136
Study Coordinator: Danielle Dawson, Research Nurse
Contact phone number: 02895048253