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

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norgine
• Treatments: Polyethylene glycol 3350

Criteria

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)