Status:
COMPLETED
An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children
Lead Sponsor:
Norgine
Conditions:
Chronic Constipation
Eligibility:
All Genders
24-11 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children.
Detailed 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 bas...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
- Patients with:
- history of bowel washout within the last 2 months
- intestinal perforation or history of obstruction
- recent history of urinary tract infection (within last month)
- Hirschsprungs disease
- paralytic ileus
- toxic megacolon
- severe inflammatory conditions of the intestinal tract
- clinically uncontrolled renal/hepatic/cardiac disease(s)
- clinically uncontrolled endocrine disorder(s)
- any other severe unstable co-existing disease
- hypersensitivity to macrogol or other constituents of Movicol
- encopresis
- patients who have taken any investigational drug in the last three months
- patients or patients whose parents would in the opinion of the investigator be unable to comply with the requirements of the study.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2003
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00403897
Start Date
August 1 2001
End Date
January 1 2003
Last Update
April 16 2008
Active Locations (1)
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1
Royal Children's Hospital
Parkville, Victoria, Australia, 3052