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

Chronic Constipation Clinical Trial

Official title:

An Open Single Centre Study To Assess the Safety and Efficacy of Movicol in the Treatment of Chronic Constipation in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403897
• Other study ID #: 99/04
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2006
• Last updated: April 15, 2008
• Start date: August 2001
• Est. completion date: January 2003

Study information

• Verified date: April 2008
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 11 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• Polyethylene glycol 3350 Na bicarbonate NaCl KCl
6.9g sachet, oral

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Parkville	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Attar A, Lémann M, Ferguson A, Halphen M, Boutron MC, Flourié B, Alix E, Salmeron M, Guillemot F, Chaussade S, Ménard 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
Secondary	Assessment of
Secondary	abdominal pain
Secondary	amount of stool
Secondary	faecal form (Bristol stool scale)
Secondary	rectal bleeding
Secondary	pain on defaecation
Secondary	straining on defaecation
Secondary	stool withholding
Secondary	faecal incontinence (soiling)
Secondary	efficacy (investigator and parental assessment)
Secondary	concomitant laxative treatment