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

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00403819
First received: November 24, 2006
Last updated: November 27, 2006
Last verified: November 2006
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Norgine:

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

Estimated Enrollment: 60
Study Start Date: April 2002
Estimated Study Completion Date: April 2003
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.

  Eligibility

Ages Eligible for Study:   24 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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: NCT00403819

Locations
United Kingdom
Aberdeen Children's Hospital
Aberdeen, United Kingdom, AB25 2ZN
University Hospital of Wales, Children's Hospital, North Ward
Cardiff, United Kingdom, CF14 4XW
Royal Hospital for Sick Children, University Hospitals NHS Trust
Edinburgh, United Kingdom, EH9 1LF
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Royal Free Hospital
London, United Kingdom, NW3 2PF
New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: Michael A Thomson, MD Royal Free Hospital NHS Foundation Trust
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00403819     History of Changes
Other Study ID Numbers: 2000/01
Study First Received: November 24, 2006
Last Updated: November 27, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014