Lubiprostone for the treatment of paediatric functional constipation
Research type
Research Study
Full title
A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years with Functional Constipation
IRAS ID
145189
Contact name
Nikhil Thapar
Contact email
Sponsor organisation
Sucampo AG
Eudract number
2013-003468-30
Duration of Study in the UK
2 years, 0 months, 7 days
Research summary
This is a phase 3 multicentre, randomised, placebo-controlled, double-blinded study that plans to investigate the efficacy and safety of a medication named lubiprostone for the treatment of functional constipation in children between 6 and 18 years old.
Symptoms of constipation in children include infrequent bowel movements (BMs), hard stools, and painful passage of stools. There is a tendency to avoid defecation and withhold BMs as a result of pain experienced from the passage of large stools. This withholding of BMs can result in episodes of faecal incontinence. Constipation occurs in all paediatric age groups, from newborns to young adults and its severity may vary from mild and short-lived to severe and chronic with faecal impaction. Constipation is the reason for 3–5% of paediatric outpatient visits and 25% of paediatric gastroenterology consultations.
Medical treatment is aimed at disimpaction of the impacted faeces and restoration of regular bowel habits, which consist of passage of soft, normal stools without discomfort. The administration of laxatives is also used to achieve a normal bowel habit of passing a soft stool without pain. Even though the traditional treatment is well established and safe, for many patients it does not provide a satisfying improvement, prompting interest in other alternatives of treatment.
Approximately 507 participants in 100 centres across different countries will be selected to take part in this study. Participants will be assigned treatment to receive either oral lubiprostone or placebo (169 for placebo and 338 for lubiprostone).
Duration of participation is approximately 16 weeks from the beginning of the screening period through follow-up.REC name
London - Bloomsbury Research Ethics Committee
REC reference
14/LO/0565
Date of REC Opinion
25 Jul 2014
REC opinion
Further Information Favourable Opinion