A study to find out if orvepitant is safe to use and reduces coughing
Research type
Research Study
Full title
A double-blind, randomized, placebo controlled study of the efficacy and safety of three doses of orvepitant in subjects with chronic refractory cough.
IRAS ID
227279
Contact name
Connie Sweeney
Contact email
Sponsor organisation
NeRRe Therapeutics Ltd.
Eudract number
2016-004979-49
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Chronic refractory cough (CRC) is a condition in which patients cough repeatedly for no obvious reason. CRC can be socially disruptive. It can also interfere with sleep, cause urinary incontinence and may sometimes cause complications such as chest and abdominal pains, retching and vomiting. The cause of CRC is not fully understood and there are currently no good treatments available for it.
NeRRe Therapeutics Ltd is sponsoring this study which is testing a new drug called orvepitant to see if this study drug might be a safe and effective treatment for CRC. It is thought that a molecule called Substance P might be partly responsible for CRC and orvepitant works by blocking Substance P.
Participants who are eligible will participate in the study for about 17 weeks and take orvepitant or placebo for 12 weeks during that time. There will be seven clinic visits and subjects will need to wear an automated cough monitor for 24 hours on four occasions. Other assessments include questionnaires and blood and urine tests. Up to 320 participants will take part in this study at clinics in the UK and USA.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0255
Date of REC Opinion
25 Jul 2017
REC opinion
Further Information Favourable Opinion