Movicol in Childhood Constipation (ProMotion Study)
Information source: Norgine
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Constipation
Intervention: Polyethylene glycol 3350 NA bicarbonate NaCl KCl (Movicol) (Drug); Lactulose (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Norgine Official(s) and/or principal investigator(s):
David CA Candy, MD, Principal Investigator, Affiliation: St Richard's Hospital
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
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.
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
Minimum age: 2 Years.
Maximum age: 11 Years.
Gender(s): Both.
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
Locations and Contacts
St Richard's Hospital, Royal West Sussex Hospital NHS Trust, Chichester PO19 4SE, United Kingdom
Additional Information
Related 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 Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30.
Starting date: October 2000
Ending date: July 2002
Last updated: November 27, 2006
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