A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an open label post study follow-up, to assess the efficacy and safety of Movicol in the treatment of chronic constipation in children
After a baseline period of 1 (one) week, subjects who had met the inclusion criteria were entered into the treatment phase of the study. Patients were randomised to receive either Movicol or matching Placebo for two (2) weeks. Following the treatment phase, patients underwent a two (2)-week placebo washout period prior to crossing over to receive the alternative treatment e.g. those patients who took Movicol were given the matching Placebo or vice versa on completion of the washout period for two (2) weeks. On completion of the double blind treatment phase, patients were given the option to participate in the eight (8) week open label post study follow-up. Patients who participated in the post study follow-up received Movicol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Aberdeen Children's Hospital
Aberdeen, United Kingdom
University Hospital of Wales, Children's Hospital, North Ward
Cardiff, United Kingdom
Royal Hospital for Sick Children, University Hospitals NHS Trust
Edinburgh, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Mean number of complete defaecations per week in each treatment period
Mean total number of defaecations (complete plus incomplete) per week in each treatment period
Pain on defaecation
Straining on defaecation
Abdominal pain
Faecal incontinence
Stool consistency
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Royal Free Hospital
London, United Kingdom
New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, United Kingdom