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

NCT00403897 | Completed Phase 3

• 1 other identifier: 99/04
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Constipation

Keywords

Constipation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (11)

• Assessment of

• abdominal pain

• amount of stool

• faecal form (Bristol stool scale)

• rectal bleeding

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Polyethylene glycol 3350 Na bicarbonate NaCl KCl DRUG

6.9g sachet, oral

Also known as: MOVICOL

1

Eligibility Criteria

• Age: 24 Months - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• /4 or more of bowel movements with straining
• /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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Related Publications (1)

• 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.

  PMID: 9895382 BACKGROUND

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Winita Hardikar, MD

  Royal Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2006
• First Posted: November 27, 2006
• Study Start: August 1, 2001
• Study Completion: January 1, 2003
• Last Updated: April 16, 2008

Record last verified: 2008-04

Locations

AU (1)