Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
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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.
Condition or disease
Gastreoesophageal Reflux Disease
Drug: Administration of omeprazole suspensionDrug: omeprazole administered as a multi-unit-pellet system
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Layout table for eligibility information
Ages Eligible for Study:
up to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Treatment with ciclosporine, tacrolimus, mycofenolate
Treatment with anticoagulants
Recent start of treatment with known inhibitors of the omeprazole-metabolism
Moderate to severe hepatic impairment (SGPT and/or AST > 3 times upper limit)