Status:
COMPLETED
Movicol in Childhood Constipation (ProMotion Study)
Lead Sponsor:
Norgine
Conditions:
Chronic Constipation
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 II was a 12 week randomised double blind comparison of Movicol and Lactulose Dry as maintenance therapy on an out-patient ...
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 remain...
Eligibility Criteria
Inclusion
- 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
- 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 :
July 1 2002
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00404040
Start Date
October 1 2000
End Date
July 1 2002
Last Update
November 28 2006
Active Locations (1)
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1
St Richard's Hospital, Royal West Sussex Hospital NHS Trust
Chichester, United Kingdom, PO19 4SE