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The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
children aged 24 months - 11 years old inclusive
patients with constipation defined as:
≤ 2 spontaneous complete bowel movements per week (over the previous 14 days), and one or more of the following:
patients in whom these symptoms have been present for ≥ 3 months
new patients or those whose management is unsatisfactory on current laxative treatment
patients of either sex
patients of any ethnic origin
hospital in-patients or outpatients.
Exclusion criteria
Patients with:
Primary purpose
Allocation
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Masking
81 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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