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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Chronic Constipation	Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	81 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open Single Centre Study To Assess the Safety and Efficacy of Movicol in the Treatment of Chronic Constipation in Children
Study Start Date :	August 2001
Study Completion Date :	January 2003

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; 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;	Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl; 6.9g sachet, oral; Other Name: MOVICOL

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Assessment of
2. abdominal pain
3. amount of stool
4. faecal form (Bristol stool scale)
5. rectal bleeding
6. pain on defaecation
7. straining on defaecation
8. stool withholding
9. faecal incontinence (soiling)
10. efficacy (investigator and parental assessment)
11. concomitant laxative treatment

Eligibility Criteria

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Ages Eligible for Study:	24 Months to 11 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052

Sponsors and Collaborators

Norgine

Investigators

Principal Investigator:	Winita Hardikar, MD	Royal Children's Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Responsible Party:	Dr Mike Geraint, Norgine
ClinicalTrials.gov Identifier:	NCT00403897 History of Changes
Other Study ID Numbers:	99/04
First Posted:	November 27, 2006
Last Update Posted:	April 16, 2008
Last Verified:	April 2008

Keywords provided by Norgine:

Constipation

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms	Polyethylene glycol 3350; Laxatives; Gastrointestinal Agents