Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Rijnstate Hospital17 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Esophageal Atresia Hernia, Diaphragmatic

Interventions

Omeprazole rectally 1mg/kgDRUG

A single dose of 1 mg/kg rectally administered omeprazole.

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 3 Months

Medical Language ↔ Plain English

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.

Locations (1)

Erasmus Medical center

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Therapeutic efficacy

Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.

Time frame: 24 hour

Secondary Outcomes

Intragastric pH

Secondary: outcomes were the percentage of time gastric pH was \<3 and \<4

Time frame: 24 hours

Maximum plasma concentration (Cmax)

The maximal concentration of OME, OH-OME and OME-S in plasma (Cmax)

Time frame: 8 hours

Time to reach Cmax (Tmax)

time to reach Cmax (Tmax)

Time frame: 8 hours

Area under the curve (AUC)

The AUC from time zero to the last sampling time point (AUC0-t)

Time frame: 8 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.