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
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2000
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 24, 2006
CompletedFirst Posted
Study publicly available on registry
November 27, 2006
CompletedNovember 28, 2006
November 1, 2006
November 24, 2006
November 27, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norginelead
Study Sites (1)
St Richard's Hospital, Royal West Sussex Hospital NHS Trust
Chichester, PO19 4SE, United Kingdom
Related Publications (3)
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
BACKGROUNDAttar 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. doi: 10.1136/gut.44.2.226.
PMID: 9895382BACKGROUNDCandy DC, Edwards D, Geraint M. Treatment of faecal impaction with polyethelene glycol plus electrolytes (PGE + E) followed by a double-blind comparison of PEG + E versus lactulose as maintenance therapy. J Pediatr Gastroenterol Nutr. 2006 Jul;43(1):65-70. doi: 10.1097/01.mpg.0000228097.58960.e6.
PMID: 16819379RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David CA Candy, MD
St. Richard's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 24, 2006
First Posted
November 27, 2006
Study Start
October 1, 2000
Study Completion
July 1, 2002
Last Updated
November 28, 2006
Record last verified: 2006-11