Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

October 4, 2019 updated by: Rijnstate Hospital

Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Oral omeprazole
Standard of care: A single dose of 1 mg/kg orally administered omeprazole.
Active Comparator: Rectal omeprazole
A single dose of 1 mg/kg rectally administered omeprazole.
Drug: Omeprazole rectally 1mg/kg
A single dose of 1 mg/kg rectally administered omeprazole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic efficacy
Time Frame: 24 hour
Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.
24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intragastric pH
Time Frame: 24 hours
Secondary: outcomes were the percentage of time gastric pH was <3 and <4
24 hours
Maximum plasma concentration (Cmax)
Time Frame: 8 hours
The maximal concentration of OME, OH-OME and OME-S in plasma (Cmax)
8 hours
Time to reach Cmax (Tmax)
Time Frame: 8 hours
time to reach Cmax (Tmax)
8 hours
Area under the curve (AUC)
Time Frame: 8 hours
The AUC from time zero to the last sampling time point (AUC0-t)
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Collaborators

Erasmus Medical Center

Investigators

  • Study Director: S.N. de Wildt, Prof. Dr., Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2005

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 22, 2005

First Submitted That Met QC Criteria

September 22, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Actual)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 4, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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