An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children
Primary Purpose
Chronic Constipation
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Polyethylene glycol 3350 Na bicarbonate NaCl KCl
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Constipation focused on measuring Constipation
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
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.
Sites / Locations
- Royal Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Ages 2 - 6: Day 1= 1 sachet/day; Day 3= 1 sachet BID; Day 5= 1 sachet TID Ages 7 - 11: Day 1= 1 sachet BID; Days 3 & 5 = 2 sachets BID;
Outcomes
Primary Outcome Measures
The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
Secondary Outcome Measures
Assessment of
abdominal pain
amount of stool
faecal form (Bristol stool scale)
rectal bleeding
pain on defaecation
straining on defaecation
stool withholding
faecal incontinence (soiling)
efficacy (investigator and parental assessment)
concomitant laxative treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00403897
Brief Title
An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children
Official Title
An Open Single Centre Study To Assess the Safety and Efficacy of Movicol in the Treatment of Chronic Constipation in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Norgine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 baseline assessment of their bowel movements over the previous 14 days were made. Patients were dispensed with Movicol to commence treatment on the following day (Day 1). During the first 5 days the dose was increased on an every second day basis until normal bowel movement was achieved. Thereafter until the end of the study the dosage was titrated according to the stool consistency (diarrhoea, loose stool, hard stools or no bowel movement for 2 days, respectively).
Four on-treatment visits were performed on Day 14 (Visit 2), Day 28 (Visit 3), Day 56 (Visit 4) and Day 84 (Visit 5). At each visit bowel movements over the previous period were assessed by the investigator using the patient's daily diary card data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Ages 2 - 6: Day 1= 1 sachet/day; Day 3= 1 sachet BID; Day 5= 1 sachet TID Ages 7 - 11: Day 1= 1 sachet BID; Days 3 & 5 = 2 sachets BID;
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol 3350 Na bicarbonate NaCl KCl
Other Intervention Name(s)
MOVICOL
Intervention Description
6.9g sachet, oral
Primary Outcome Measure Information:
Title
The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
Secondary Outcome Measure Information:
Title
Assessment of
Title
abdominal pain
Title
amount of stool
Title
faecal form (Bristol stool scale)
Title
rectal bleeding
Title
pain on defaecation
Title
straining on defaecation
Title
stool withholding
Title
faecal incontinence (soiling)
Title
efficacy (investigator and parental assessment)
Title
concomitant laxative treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winita Hardikar, MD
Organizational Affiliation
Royal Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
9895382
Citation
Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30. doi: 10.1136/gut.44.2.226.
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An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children
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