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Movicol in Childhood Constipation (ProMotion Study)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00403858
First Posted: November 27, 2006
Last Update Posted: January 4, 2007
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.
Information provided by:
Norgine
  Purpose
This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day open label evaluation of Movicol administered to patients in hospital. This study evaluated the safety and efficacy of Movicol in treating faecal impaction. Movicol was administered over 3 - 7 days to achieve disimpaction.

Condition Intervention Phase
Feces, Impacted Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol) Drug: Lactulose Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Centre Study to Assess the Safety and Efficacy of Movicol in the Treatment of Faecal Impaction in Children Followed by a Double Blind, Randomised Phase to Compare the Safety and Efficacy of Movicol and Lactulose for Maintenance Therapy

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children.

Estimated Enrollment: 60
Study Start Date: October 2000
Estimated Study Completion Date: April 2002
Detailed Description:

Patients received Movicol treatment until disimpaction was achieved according to the following regime:

Day 1: Ages 2 – 4 received 1 (one) sachet whilst 5 – 11 year olds received 2 (two).

Day 2: Ages 2 – 4 received 2 (two) sachets whilst 5 – 11 year olds received 3 (three).

Day 3: Ages 2 – 4 received 2 (two) sachets whilst 5 – 11 year olds received 4 (four).

Day 4: Ages 2 – 4 received 3 *three) sachets whilst 5 – 11 year olds received 5 (five).

Day 5: Ages 2 – 4 received 3 (three) sachets whilst 5 – 11 year olds received 6 (six).

Day 6: Ages 2 – 4 received 4 (four) sachets whilst 5 – 11 year olds received 6 (six).

Day 7: Ages 2 – 4 received 4 (four) sachets whilst 5 – 11 year olds received 6 (six).

If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs. Disimpaction was assessed clinically (loss of faecal masses and passage of watery stools).

Two days following disimpaction patients were randomised (according to the randomisation list) to receive Movicol or Lactulose Dry. During bowel retraining the appropriate maintenance dose of Movicol or Lactulose Dry was determined. Patients were discharged once they were passing regular, painless, bowel actions.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients that, in the opinion of the investigator, are constipated/fecally impacted as to require hospital stay to treat and/or relieve the impaction
  • children aged 2 - 11 years old inclusive
  • patients of either sex

Exclusion Criteria:

Patients with

  • intestinal perforation or obstruction
  • severe inflammatory conditions of the intestinal tract
  • uncontrolled renal/hepatic/cardiac diseases
  • uncontrolled endocrine disorder(s)
  • any neuromuscular condition affecting bowel function
  • hypersensitivity to lactulose or PEG or other constituent of Movicol
  • patients who have taken any investigational drug in the three months
  • patients or patients whose parents would in the opinion of the investigator are unable to comply with requirements of the study
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00403858


Locations
United Kingdom
St Richard's Hospital, Royal West Sussex Hospital NHS Trust
Chichester, United Kingdom, PO19 4SE
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: David CA Candy, MD St Richard's Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00403858     History of Changes
Other Study ID Numbers: 99/05 (Part I)
First Submitted: November 24, 2006
First Posted: November 27, 2006
Last Update Posted: January 4, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Fecal Impaction
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Polyethylene glycol 3350
Lactulose
Gastrointestinal Agents
Laxatives