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

November 24, 2006
November 27, 2006
October 2000
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compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.
compare the safety and efficacy of Movicol and Duphalac Dry as maintenance therapy.
Complete list of historical versions of study NCT00404040 on ClinicalTrials.gov Archive Site
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Movicol in Childhood Constipation (ProMotion Study)
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Constipation
  • Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)
  • Drug: Lactulose
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2002
Not Provided

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
Both
2 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00404040
99/05 (Part II)
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Norgine
Not Provided
Principal Investigator: David CA Candy, MD St Richard's Hospital
Norgine
November 2006

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