Status:
COMPLETED
Movicol in Childhood Constipation (ProMotion Study)
Lead Sponsor:
Norgine
Conditions:
Feces, Impacted
Eligibility:
All Genders
2-11 years
Phase:
PHASE2
Brief Summary
This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day open label evaluation of Movicol administered to patients in hospital. This study evaluated the safety and e...
Detailed Description
Patients received Movicol treatment until disimpaction was achieved according to the following regime: Day 1: Ages 2 - 4 received 1 (one) sachet whilst 5 - 11 year olds received 2 (two). Day 2: Ages...
Eligibility Criteria
Inclusion
- patients that, in the opinion of the investigator, are constipated/fecally 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
- 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
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
April 1 2002
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00403858
Start Date
October 1 2000
End Date
April 1 2002
Last Update
January 4 2007
Active Locations (1)
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1
St Richard's Hospital, Royal West Sussex Hospital NHS Trust
Chichester, United Kingdom, PO19 4SE