Esophageal Atresia, Gastroesophageal Reflux, Hernia, Diaphragmatic
Conditions
Keywords
Omeprazole, suppository, infants
Brief summary
The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.
Detailed description
Omeprazole is a highly effective drug for the treatment of gastroesophageal reflux disease (GERD) in infants. Infants, aged 0-12 months, require a non-standard dose of omeprazole. Due to this fact extemporaneous formulations of omeprazole are administered to these infants. The oral bioavailability of omeprazole in nonproprietary formulations may be unpredictable and produce variable degrees of drug exposure. The dose range for GERD management in pediatric studies using omeprazole is 0.3 - 3.5 mg/kg/day. Dosing information, aged-specific pharmacodynamic and pharmacokinetic data are not available in infants, aged 0-12 months. Two adult studies at healthy volunteers suggest that an omeprazole suppository is an effective dosage form.This study is designed to evaluate and to compare the efficacy, the pharmacodynamics and the pharmacokinetics of oral and rectal omeprazole treatment in infants with gastroesophageal reflux disease.
Interventions
DRUGOmeprazole rectally 1mg/kg
A single dose of 1 mg/kg rectally administered omeprazole.
Sponsors
Erasmus Medical Center
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study was an open-label randomized intervention trial to study the efficacy of a single oral or rectal administered omeprazole dose of 1 mg/kg in infants with GERD due to EA or CDH.
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 3 Months
Healthy volunteers
No
Inclusion criteria
Infants were eligible for the study if they were: * 6-12 weeks postnatal age * weighed more than 3 kg * were after surgical repair for EA or CDH * showed clinical GERD * were to undergo the 48 hour pH measurements. Infants were excluded if they were: * allergic to omeprazole * participated in other interventional trials * used medications known to interact with omeprazole.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic efficacy | 24 hour | Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intragastric pH | 24 hours | Secondary: outcomes were the percentage of time gastric pH was \<3 and \<4 |
| Maximum plasma concentration (Cmax) | 8 hours | The maximal concentration of OME, OH-OME and OME-S in plasma (Cmax) |
| Time to reach Cmax (Tmax) | 8 hours | time to reach Cmax (Tmax) |
| Area under the curve (AUC) | 8 hours | The AUC from time zero to the last sampling time point (AUC0-t) |
Countries
Netherlands
Outcome results
None listed