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

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ClinicalTrials.gov Identifier: NCT00403819
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : November 28, 2006
Sponsor:
Information provided by:
Norgine

Tracking Information
First Submitted Date  ICMJE November 24, 2006
First Posted Date  ICMJE November 27, 2006
Last Update Posted Date November 28, 2006
Study Start Date  ICMJE April 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2006)
Mean number of complete defaecations per week in each treatment period
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00403819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Chronic Constipation
Intervention  ICMJE Drug: Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Movicol)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 24, 2006)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Months to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00403819
Other Study ID Numbers  ICMJE 2000/01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Norgine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael A Thomson, MD Royal Free Hospital NHS Foundation Trust
PRS Account Norgine
Verification Date November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP