Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children

Inclusion Criteria:

Male and female patients of any ethnic origin will be eligible to participate in the study if all of the following criteria are fulfilled.

• informed consent having been obtained from the patient's parent or guardian and assent from the child if they are capable of understanding the study
• aged 24 months - 11 years

• experiencing constipation as defined as:

  • ≤2 complete bowel movements per week, and at least one of the following:

    • pain on defaecation on ≥1 in 4 days
    • 1/4 or more of bowel movements with straining
    • 1/4 or more of bowel movements with hard or lumpy stools
• patients in whom these symptoms have been present for ≥3 months
• available to complete the study and able to comply with requirements and restrictions listed in the patient's/parent's information documents.

Exclusion Criteria:

Patients will not be eligible to participate in the study if any of the following conditions apply:

• faecal impaction or history of faecal impaction
• history of intestinal perforation or constipation
• paralytic ileus
• toxic megacolon
• Hirschsprungs disease
• severe inflammatory conditions of the intestinal tract
• severe gastro-oesophageal reflux - that which is complicated by anaemia, haematemesis, respiratory aspiration, failure to thrive or other recognised complications of gastro-oesophageal reflux
• patients currently receiving over 0.5mg/kg/day of senna or over 1/2 sachet of sodium picosulphate per day for children <6 years and over 1 sachet sodium picosulphate per day for children > 6 years (i.e. high doses of stimulant laxatives)
• any other significant medical condition that in the investigator's opinion would effect their suitability for entry into the study
• patients who have previously received Movicol or previously participated in the study
• known hypersensitivity to polyethylene (PEG) 3350 or any of the constituents of Movicol
• patients with diabetes as the placebo to be used in this study is sucrose
• patients who have received any investigational drug in the last 3 months
• patients and/or parents who the investigator thinks could not comply with the requirements of the protocol for any reason (particularly in relation to reliable completion of diary cards)