Movicol in Childhood Constipation (ProMotion Study)

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00404040
First received: November 24, 2006
Last updated: November 27, 2006
Last verified: November 2006
  Purpose

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 Intervention Phase
Chronic Constipation
Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)
Drug: Lactulose
Phase 2

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 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:
  • compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.

Estimated Enrollment: 60
Study Start Date: October 2000
Estimated Study Completion Date: July 2002
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.

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00404040

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: NCT00404040     History of Changes
Other Study ID Numbers: 99/05 (Part II)
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, Digestive
Signs and Symptoms
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014