Status:
COMPLETED
Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
Lead Sponsor:
University Hospital, Ghent
Conditions:
Gastreoesophageal Reflux Disease
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief Summary
Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of th...
Eligibility Criteria
Inclusion
- Children \> 15 kg
- Cerebral palsy and mental retardation with swallowing disorders
- Presence of gastrostomy tube
- GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks
- Informed consent
Exclusion
- Treatment with ciclosporine, tacrolimus, mycofenolate
- Treatment with anticoagulants
- Infection
- Recent start of treatment with known inhibitors of the omeprazole-metabolism
- Moderate to severe hepatic impairment (SGPT and/or AST \> 3 times upper limit)
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00426595
Start Date
April 1 2007
End Date
November 1 2007
Last Update
April 10 2009
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000