Clinical Trial: Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokineti

Brief 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.

Detailed Summary:

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.


Sponsor: Rijnstate Hospital

Current Primary Outcome: Therapeutic efficacy

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intragastric pH, Pharmacokinetic parameters, PK-PD-relation,
  • Pharmacogenetic parameters


Original Secondary Outcome:

  • Intragastric pH, Pharmocokinetic parameters, PK-PD-relation,
  • Pharmacogenetic parameters


Information By: Rijnstate Hospital

Dates:
Date Received: September 22, 2005
Date Started: September 2005
Date Completion: December 2007
Last Updated: April 25, 2013
Last Verified: April 2013