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Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

NCT00226044 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-10-07

No results posted yet for this 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.

Conditions

  • Gastroesophageal Reflux
  • Esophageal Atresia
  • Hernia, Diaphragmatic

Interventions

DRUG

Omeprazole rectally 1mg/kg

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

Sponsors & Collaborators

Principal Investigators

  • S.N. de Wildt, Prof. Dr. · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2016-09-30
Completion
2017-09-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00226044 on ClinicalTrials.gov