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

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 2

Conditions

Gastreoesophageal Reflux Disease

Treatments

Drug: omeprazole administered as a multi-unit-pellet system

Drug: Administration of omeprazole suspension

Study type

Interventional

Funder types

Other

Identifiers

NCT00426595

2007/013

Details and patient eligibility

About

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.

Enrollment

14 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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