The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children.
This was a phase III, open, single centre, non-comparative study. All patients were assigned to treatment with Movicol for a period of 12 weeks. All patients were screened at Day 0 (Visit 1) when baseline assessment of their bowel movements over the previous 14 days were made. Patients were dispensed with Movicol to commence treatment on the following day (Day 1). During the first 5 days the dose was increased on an every second day basis until normal bowel movement was achieved. Thereafter until the end of the study the dosage was titrated according to the stool consistency (diarrhoea, loose stool, hard stools or no bowel movement for 2 days, respectively). Four on-treatment visits were performed on Day 14 (Visit 2), Day 28 (Visit 3), Day 56 (Visit 4) and Day 84 (Visit 5). At each visit bowel movements over the previous period were assessed by the investigator using the patient's daily diary card data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
6.9g sachet, oral
Royal Children's Hospital
Parkville, Victoria, Australia
The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
Assessment of
abdominal pain
amount of stool
faecal form (Bristol stool scale)
rectal bleeding
pain on defaecation
straining on defaecation
stool withholding
faecal incontinence (soiling)
efficacy (investigator and parental assessment)
concomitant laxative treatment
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