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Completed

NCT Number: NCT00226044

Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

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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Key information

Conditions

Gastroesophageal Reflux Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deglutition Disorders Digestive System Abnormalities Digestive System Diseases Esophageal Atresia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

6 week–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erasmus Medical center

Rotterdam, 3015 GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omeprazole rectally 1mg/kg

Drug

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

Primary outcomes

  1. Therapeutic efficacy

    Time frame: 24 hour

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

Secondary outcomes

  1. Intragastric pH

    Time frame: 24 hours

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

  2. Maximum plasma concentration (Cmax)

    Time frame: 8 hours

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

  3. Time to reach Cmax (Tmax)

    Time frame: 8 hours

    time to reach Cmax (Tmax)

  4. Area under the curve (AUC)

    Time frame: 8 hours

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

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Erasmus Medical Center

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2016
Study completion
2017
First posted
Sep 26, 2005
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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