Gastreoesophageal Reflux Disease
Conditions
Brief summary
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.
Interventions
DRUGAdministration of omeprazole suspension
DRUGomeprazole administered as a multi-unit-pellet system
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (at the end of the treatment period of 14 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastric pH (at the end of the treatment period of 14 days) | — |
Countries
Belgium
Outcome results
None listed