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

Norgine

Status and phase

Completed

Phase 3

Conditions

Chronic Constipation

Treatments

Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00403819

2000/01

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

24 months to 11 years old

Volunteers

No Healthy Volunteers

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)