Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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.

Intervention(s) in this Clinical Trial

• Drug: Omeprazole suppository

Primary Measures

• Therapeutic efficacy

Secondary Measures

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

Inclusion Criteria:

• age 6-12 weeks
• weight: 3 kg or > 3 kg
• gastroesophageal reflux as a result of esophageal atresia or congenital diaphragmatic hernia.
• Informed consent of both parents

Exclusion Criteria:

• Allergy to omeprazole
• Infants with gastroesophageal reflux as a result of congenital errors of CNS
• Changes in the co-medication during the study
• Participation in a study that is interfering with this study.
• The use of the following co-medication: alprazolam, midazolam, triazolam, carbamazepine, clorazepate, ciclosporin, disulfiram, phenytoin, iron, itraconazole, ketoconazole, voriconazole, methotrexate, ticlopidine, warfarin.
• Infants of the non-Caucasian race

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Weeks

Maximum Age for this Clinical Trial: 3 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Rijnstate Hospital

Overall Clinical Trial Officials and Contacts

D. Tibboel, Prof. Dr. Study Director Erasmus Medical Center  

Overall Contact: P. Bestebreurtje, Pharm D +31355391398 pbestebreurtje@tergooiziekenhuizen.nl

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00226044

Study ID Number: LTC-001

ClinicalTrials.gov Identifier: NCT00226044

Health Authority: Netherlands: Dutch Health Care Inspectorate