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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403897
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : April 16, 2008
Information provided by:

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403897

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Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Sponsors and Collaborators
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Principal Investigator: Winita Hardikar, MD Royal Children's Hospital
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Responsible Party: Dr Mike Geraint, Norgine Identifier: NCT00403897    
Other Study ID Numbers: 99/04
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008
Keywords provided by Norgine:
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Polyethylene glycol 3350
Gastrointestinal Agents