Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Last updated: October 4, 2019
Sponsor: Rijnstate Hospital
Overall Status: Completed

Phase

3

Condition

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00226044
LTC-001
  • Ages 6-3
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 17
Study Start date:
September 01, 2005
Estimated Completion Date:
September 30, 2017

Study 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.

Connect with a study center

  • Erasmus Medical center

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

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