Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
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 the acid-labile proton pump inhibitor omeprazole is often problematic in
these patients who may be suffering from swallowing disorders. A suspension of omeprazole in
a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This
trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy
tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus
the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The
crossover study will consist of 2 consecutive treatment periods of 14 days.