Phase 3b Gefapixant for Chronic Cough and Stress Urinary Incontinence
Research type
Research Study
Full title
A Phase 3b Randomized Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Women with Chronic Cough and Stress Urinary Incontinence
IRAS ID
273063
Contact name
Surrinder Birring
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Eudract number
2019-002321-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 21 days
Research summary
Chronic cough, defined as a cough lasting >8 weeks, is a common complaint worldwide and one of the most frequent concerns prompting patients to seek a physician consultation. The overall global prevalence of chronic cough is approximately 10%. Given the prolonged nature, significant morbidity, lack of effective treatment, unexplained or refractory chronic cough is a major unmet medical need.
Stress urinary incontinence (SUI), defined as the involuntary loss of urine in association with increased intra-abdominal pressure from coughing, sneezing or physical exertion is the most common type of urinary incontinence in women, with an overall prevalence ranging from 29% to 75% depending on age.
Cough is initiated following activation of airway sensory nerves, mainly C-fibre sensory neurons, in the upper and lower respiratory tract. P2X3 receptors respond to Adenosine Triphosphate (ATP) which is released by damaged, stressed, and inflamed tissues. The drug to be tested in this study is gefapixant (MK-7264) which is a P2X3 receptor antagonist. Gefapixant can bind to the P2X3 receptor, preventing ATP binding and thereby prevent the cough response from occurring.
This study is to evaluate the efficacy and safety of gefapixant in improving symptoms of SUI in adult female participants with refractory or unexplained chronic cough and SUI.
In this study, participants will receive treatment twice daily with either MK-7264 (45 mg) or placebo in a 1:1 ratio for a 12-week intervention period. Episodes of cough-induced stress urinary incontinence, determined by a participant incontinence diary, will be measured as percentage change from the beginning of the study (baseline).
Approximately 380 participants will take part in the study which will last approximately 17 months. Each participant will be in the study for approximately 22 weeks. The study will take place at 4 sites in the UK and is funded by Merck Sharp & Dohme Limited.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1840
Date of REC Opinion
9 Dec 2019
REC opinion
Favourable Opinion