Status:
COMPLETED
Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children
Lead Sponsor:
Norgine
Conditions:
Chronic Constipation
Eligibility:
All Genders
24-11 years
Phase:
PHASE3
Brief 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 c...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2003
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00403819
Start Date
April 1 2002
End Date
April 1 2003
Last Update
November 28 2006
Active Locations (6)
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1
Aberdeen Children's Hospital
Aberdeen, United Kingdom, AB25 2ZN
2
University Hospital of Wales, Children's Hospital, North Ward
Cardiff, United Kingdom, CF14 4XW
3
Royal Hospital for Sick Children, University Hospitals NHS Trust
Edinburgh, United Kingdom, EH9 1LF
4
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW