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

April 15, 2008 updated by: Norgine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • MOVICOL

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norgine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion

January 1, 2003

Study Registration Dates

First Submitted

November 24, 2006

First Submitted That Met QC Criteria

November 24, 2006

First Posted (ESTIMATE)

November 27, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2008

Last Update Submitted That Met QC Criteria

April 15, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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