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

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00403897
First received: November 24, 2006
Last updated: April 15, 2008
Last verified: April 2008
History of Changes
  Purpose
The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children.

Condition Intervention Phase
Chronic Constipation
 Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norgine:

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

Secondary Outcome Measures:
  • 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
Enrollment: 81
Study Start Date: August 2001
Estimated Study Completion Date: January 2003
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   24 Months to 11 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403897

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

Publications:

Responsible Party: Dr Mike Geraint, Norgine
ClinicalTrials.gov Identifier: NCT00403897     History of Changes
Other Study ID Numbers: 99/04 
Study First Received: November 24, 2006
Last Updated: April 15, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Norgine:
Constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
 Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 30, 2016