Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation

Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation

Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation

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.

Inclusion Criteria: 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 Criteria: 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)