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)