Prucalopride in Systemic Sclerosis
Research type
Research Study
Full title
A RANDOMISED PLACEBO CONTROLLED DRUG TRIAL OF PRUCALOPRIDE VERSUS PLACEBO FOR CONSTIPATION IN SYSTEMIC SCLEROSIS
IRAS ID
161384
Contact name
Anton Emmanuel
Contact email
Sponsor organisation
University College London
Eudract number
2013-004883-69
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Almost 80% of patients with Scleroderma experience lower gut symptoms and over 50% are affected by chronic constipation. There are many laxatives on the market but these are usually ineffective for constipation in Scleroderma patients as they worsen bloating and pain along with predisposing to faecal incontinence. This can have a significantly debilitating effect on quality of life, with patients opting to stay at home with concerns regarding public toilets and the fear of accidents. Prucalopride, is a novel agent that is hypothesized to improve bowel frequency without worsening the pain or bloating and is well tolerated.
We hypothesize that Prucalopride will significantly improve scleroderma associated constipation compared to placebo (inactive drug). There is little clinical data on its use in Scleroderma patients and as constipation affects a high proportion, Prucalopride could improve clinical practice if proven to be effective over placebo. It could lower NHS costs incurred by the use of many different laxatives and reduce referrals for more invasive treatments for constipation such as rectal irrigation and manual dis impaction or surgery.
REC name
London - South East Research Ethics Committee
REC reference
15/LO/0809
Date of REC Opinion
6 Jul 2015
REC opinion
Further Information Favourable Opinion