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

Primary Purpose

Chronic Constipation

Status

Completed

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

Polyethylene glycol 3350 Na bicarbonate NaCl KCl

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Constipation

Eligibility Criteria

24 Months - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Royal Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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;

Outcomes

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

Full Information

NCT ID

NCT00403897

First Posted

November 24, 2006

Last Updated

April 15, 2008

Sponsor

Norgine

1. Study Identification

Unique Protocol Identification Number

NCT00403897

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

August 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Norgine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Constipation

Keywords

Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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;

Intervention Type

Drug

Intervention Name(s)

Polyethylene glycol 3350 Na bicarbonate NaCl KCl

Other Intervention Name(s)

MOVICOL

Intervention Description

6.9g sachet, oral

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Assessment of

Title

abdominal pain

Title

amount of stool

Title

faecal form (Bristol stool scale)

Title

rectal bleeding

Title

pain on defaecation

Title

straining on defaecation

Title

stool withholding

Title

faecal incontinence (soiling)

Title

efficacy (investigator and parental assessment)

Title

concomitant laxative treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Months

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Winita Hardikar, MD

Organizational Affiliation

Royal Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Children's Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

9895382

Citation

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.

Results Reference

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

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