Back to results

Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children

Primary Purpose

Chronic Constipation

Status

Completed

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)

About this trial

This is an interventional treatment trial for Chronic Constipation

Eligibility Criteria

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

Inclusion Criteria:

Male and female patients of any ethnic origin will be eligible to participate in the study if all of the following criteria are fulfilled.

informed consent having been obtained from the patient's parent or guardian and assent from the child if they are capable of understanding the study
aged 24 months - 11 years
experiencing constipation as defined as:
- ≤2 complete bowel movements per week, and at least one of the following:
  - pain on defaecation on ≥1 in 4 days
  - 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
available to complete the study and able to comply with requirements and restrictions listed in the patient's/parent's information documents.

Exclusion Criteria:

Patients will not be eligible to participate in the study if any of the following conditions apply:

faecal impaction or history of faecal impaction
history of intestinal perforation or constipation
paralytic ileus
toxic megacolon
Hirschsprungs disease
severe inflammatory conditions of the intestinal tract
severe gastro-oesophageal reflux - that which is complicated by anaemia, haematemesis, respiratory aspiration, failure to thrive or other recognised complications of gastro-oesophageal reflux
patients currently receiving over 0.5mg/kg/day of senna or over 1/2 sachet of sodium picosulphate per day for children <6 years and over 1 sachet sodium picosulphate per day for children > 6 years (i.e. high doses of stimulant laxatives)
any other significant medical condition that in the investigator's opinion would effect their suitability for entry into the study
patients who have previously received Movicol or previously participated in the study
known hypersensitivity to polyethylene (PEG) 3350 or any of the constituents of Movicol
patients with diabetes as the placebo to be used in this study is sucrose
patients who have received any investigational drug in the last 3 months
patients and/or parents who the investigator thinks could not comply with the requirements of the protocol for any reason (particularly in relation to reliable completion of diary cards)

Sites / Locations

Aberdeen Children's Hospital
University Hospital of Wales, Children's Hospital, North Ward
Royal Hospital for Sick Children, University Hospitals NHS Trust
Leicester Royal Infirmary
Royal Free Hospital
New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust

Outcomes

Primary Outcome Measures

Mean number of complete defaecations per week in each treatment period

Secondary Outcome Measures

Mean total number of defaecations (complete plus incomplete) per week in each treatment period

Pain on defaecation

Straining on defaecation

Abdominal pain

Faecal incontinence

Stool consistency

Full Information

NCT ID

NCT00403819

First Posted

November 24, 2006

Last Updated

November 27, 2006

Sponsor

Norgine

1. Study Identification

Unique Protocol Identification Number

NCT00403819

Brief Title

Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children

Official Title

A Phase III Multi-Centre Placebo-Controlled Crossover Study Followed by an Open Label Post-Study Follow-up to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Completed

Study Start Date

April 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Norgine

4. Oversight

5. Study Description

Brief Summary

A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an open label post study follow-up, to assess the efficacy and safety of Movicol in the treatment of chronic constipation in children

Detailed Description

After a baseline period of 1 (one) week, subjects who had met the inclusion criteria were entered into the treatment phase of the study. Patients were randomised to receive either Movicol or matching Placebo for two (2) weeks. Following the treatment phase, patients underwent a two (2)-week placebo washout period prior to crossing over to receive the alternative treatment e.g. those patients who took Movicol were given the matching Placebo or vice versa on completion of the washout period for two (2) weeks. On completion of the double blind treatment phase, patients were given the option to participate in the eight (8) week open label post study follow-up. Patients who participated in the post study follow-up received Movicol.

6. Conditions and Keywords

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

Chronic Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)

Primary Outcome Measure Information:

Title

Mean number of complete defaecations per week in each treatment period

Secondary Outcome Measure Information:

Title

Mean total number of defaecations (complete plus incomplete) per week in each treatment period

Title

Pain on defaecation

Title

Straining on defaecation

Title

Abdominal pain

Title

Faecal incontinence

Title

Stool consistency

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: Male and female patients of any ethnic origin will be eligible to participate in the study if all of the following criteria are fulfilled. informed consent having been obtained from the patient's parent or guardian and assent from the child if they are capable of understanding the study aged 24 months - 11 years experiencing constipation as defined as: ≤2 complete bowel movements per week, and at least one of the following: pain on defaecation on ≥1 in 4 days 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 available to complete the study and able to comply with requirements and restrictions listed in the patient's/parent's information documents. Exclusion Criteria: Patients will not be eligible to participate in the study if any of the following conditions apply: faecal impaction or history of faecal impaction history of intestinal perforation or constipation paralytic ileus toxic megacolon Hirschsprungs disease severe inflammatory conditions of the intestinal tract severe gastro-oesophageal reflux - that which is complicated by anaemia, haematemesis, respiratory aspiration, failure to thrive or other recognised complications of gastro-oesophageal reflux patients currently receiving over 0.5mg/kg/day of senna or over 1/2 sachet of sodium picosulphate per day for children <6 years and over 1 sachet sodium picosulphate per day for children > 6 years (i.e. high doses of stimulant laxatives) any other significant medical condition that in the investigator's opinion would effect their suitability for entry into the study patients who have previously received Movicol or previously participated in the study known hypersensitivity to polyethylene (PEG) 3350 or any of the constituents of Movicol patients with diabetes as the placebo to be used in this study is sucrose patients who have received any investigational drug in the last 3 months patients and/or parents who the investigator thinks could not comply with the requirements of the protocol for any reason (particularly in relation to reliable completion of diary cards)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael A Thomson, MD

Organizational Affiliation

Royal Free Hospital NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aberdeen Children's Hospital

City

Aberdeen

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

University Hospital of Wales, Children's Hospital, North Ward

City

Cardiff

ZIP/Postal Code

CF14 4XW

Country

United Kingdom

Facility Name

Royal Hospital for Sick Children, University Hospitals NHS Trust

City

Edinburgh

ZIP/Postal Code

EH9 1LF

Country

United Kingdom

Facility Name

Leicester Royal Infirmary

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Royal Free Hospital

City

London

ZIP/Postal Code

NW3 2PF

Country

United Kingdom

Facility Name

New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

3578195

Citation

Issenman RM, Hewson S, Pirhonen D, Taylor W, Tirosh A. Are chronic digestive complaints the result of abnormal dietary patterns? Diet and digestive complaints in children at 22 and 40 months of age. Am J Dis Child. 1987 Jun;141(6):679-82. doi: 10.1001/archpedi.1987.04460060095043.

Results Reference

background

PubMed Identifier

3278282

Citation

Hatch TF. Encopresis and constipation in children. Pediatr Clin North Am. 1988 Apr;35(2):257-80. doi: 10.1016/s0031-3955(16)36431-8.

Results Reference

background

PubMed Identifier

8244110

Citation

Loening-Baucke V. Constipation in early childhood: patient characteristics, treatment, and longterm follow up. Gut. 1993 Oct;34(10):1400-4. doi: 10.1136/gut.34.10.1400.

Results Reference

background

PubMed Identifier

7979489

Citation

Benninga MA, Buller HA, Heymans HS, Tytgat GN, Taminiau JA. Is encopresis always the result of constipation? Arch Dis Child. 1994 Sep;71(3):186-93. doi: 10.1136/adc.71.3.186.

Results Reference

background

PubMed Identifier

8890073

Citation

Benninga MA, Buller HA, Tytgat GN, Akkermans LM, Bossuyt PM, Taminiau JA. Colonic transit time in constipated children: does pediatric slow-transit constipation exist? J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):241-51. doi: 10.1097/00005176-199610000-00007.

Results Reference

background

PubMed Identifier

9830188

Citation

Culbert P, Gillett H, Ferguson A. Highly effective new oral therapy for faecal impaction. Br J Gen Pract. 1998 Sep;48(434):1599-600.

Results Reference

background

Citation

Thomson M, Jenkins H, et al. A Placebo Controlled Crossover Study of Movicol in the Treatment of Childhood Constipation. J Pediatr Gastroenterol Nutr 2004;39(1):S16 [abstract]

Results Reference

result

Learn more about this trial

Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children

We'll reach out to this number within 24 hrs