Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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)