Movicol in Childhood Constipation (ProMotion Study)

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Constipation

Intervention / Treatment
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* Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)
* Drug: Lactulose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol)|nan|
|Drug: Lactulose|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy. |  |  |