Movicol in Childhood Constipation (ProMotion Study)

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. Identifier: NCT00404040
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : November 28, 2006
Information provided by:

Brief Summary:
This was a single centre study comprised of two stages (Parts I and II). Part II was a 12 week randomised double blind comparison of Movicol and Lactulose Dry as maintenance therapy on an out-patient basis. The aim was to evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol) Drug: Lactulose Phase 2

Detailed Description:

Two days following disimpaction (Part I of the clinical trial) patients were assigned (based on their randomisation number) to receive either Movicol or Lactulose as maintenance therapy for the remainder of the study. At discharge all patients received the appropriate supply of study medication. This includes 1 week’s overage should they miss their next visit to the ProMotion clinic. They did not know whether they have been randomised to receive Movicol or Lactulose Dry.

Following discharge patients were contacted after 3-5 days by telephone or home visit (whichever was appropriate) to encourage treatment and to ensure compliance. Parents were instructed to contact the Pro-Motion team who would advise appropriately if patients had any difficulty i.e. none, irregular and/ or uncomfortable or very loose bowel movements.

The daily use of Movicol or Lactulose Dry during Part II was recorded in the diary. If the dose of Movicol or Lactulose was changed by the Pro-Motion team at any time then it was documented appropriately in the patient notes and the case report form.

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : October 2000
Study Completion Date : July 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Primary Outcome Measures :
  1. compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • patients that, in the opinion of the investigator, are constipated/faecally 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

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 identifier (NCT number): NCT00404040

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

Publications of Results:
Other Publications:
Dalziel SR et al. Efficacy of Movicol in children with faecal impaction. A series of en case histories (A13). British Society of Paediatric Gastroenterologists Annual Meeting. Bristol:21-22, Jan 2000 Identifier: NCT00404040     History of Changes
Other Study ID Numbers: 99/05 (Part II)
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: November 28, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Polyethylene glycol 3350
Gastrointestinal Agents