An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children

Phase 3

Completed

• Conditions: Chronic Constipation
• Interventions: Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl

• Registration Number: NCT00403897
• Lead Sponsor: Norgine

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.

Study Timeline

• Study Start: 2001-08
• Study Completion: 2003-01
• Study First Submitted: 2006-11-24
• Study First Submitted QC: 2006-11-24
• Study First Posted: 2006-11-27
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-15
• Last Update Posted: 2008-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Polyethylene glycol 3350 Na bicarbonate NaCl KCl	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;

Primary Outcome Measures

Name	Time	Method
The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Children's Hospital; 🇦🇺 Parkville, Victoria, Australia