Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Esophageal Atresia Hernia, Diaphragmatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral omeprazole

Standard of care: A single dose of 1 mg/kg orally administered omeprazole.

Group Type NO_INTERVENTION

No interventions assigned to this group

Rectal omeprazole

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

Group Type ACTIVE_COMPARATOR

Omeprazole rectally 1mg/kg

Intervention Type DRUG

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

Interventions

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Omeprazole rectally 1mg/kg

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No