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.
Drug: Omeprazole suppository
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study.|
- Therapeutic efficacy
- Intragastric pH, Pharmacokinetic parameters, PK-PD-relation,
- Pharmacogenetic parameters
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||December 2007|
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.
|Contact: P. Bestebreurtje, Pharm Dfirstname.lastname@example.org|
|Erasmus Medical center||Recruiting|
|Rotterdam, Netherlands, 3015 GD|
|Contact: D. Tibboel, Prof. dr.|
|Contact: P. Bestebreurtje, Pharm D +31263786300 email@example.com|
|Sub-Investigator: A. A. van Sorge, Pharm D, PhD|
|Sub-Investigator: C AJ Knibbe, Pharm D, PhD|
|Principal Investigator: P. Bestebreurtje, Pharm D|
|Study Director:||D. Tibboel, Prof. Dr.||Erasmus Medical Center|