Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2013 by Rijnstate Hospital

Sponsor:

Collaborator:

Erasmus Medical Center

Information provided by (Responsible Party):

Rijnstate Hospital

ClinicalTrials.gov Identifier:

NCT00226044

First received: September 22, 2005

Last updated: April 25, 2013

Last verified: April 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux Esophageal Atresia Hernia, Diaphragmatic	Drug: Omeprazole suppository	Phase 3


Study Type:	Interventional
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.

Resource links provided by NLM:

Genetics Home Reference related topics: congenital diaphragmatic hernia esophageal atresia/tracheoesophageal fistula

MedlinePlus related topics: GERD Hernia

Drug Information available for: Omeprazole Omeprazole magnesium

Genetic and Rare Diseases Information Center resources: Congenital Diaphragmatic Hernia Esophageal Atresia

U.S. FDA Resources

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:

Therapeutic efficacy

Secondary Outcome Measures:

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


Estimated Enrollment:	20
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2007

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.

Eligibility


Ages Eligible for Study:	6 Weeks to 3 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226044

Contacts


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

Locations


Netherlands
Erasmus Medical center	Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: D. Tibboel, Prof. dr.
Contact: P. Bestebreurtje, Pharm D +31263786300 pbestebreurtje@tergooiziekenhuizen.nl
Sub-Investigator: A. A. van Sorge, Pharm D, PhD
Sub-Investigator: C AJ Knibbe, Pharm D, PhD
Principal Investigator: P. Bestebreurtje, Pharm D

Sponsors and Collaborators

Rijnstate Hospital

Erasmus Medical Center

Investigators


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

More Information

No publications provided


Responsible Party:	Rijnstate Hospital
ClinicalTrials.gov Identifier:	NCT00226044 History of Changes
Other Study ID Numbers:	LTC-001
Study First Received:	September 22, 2005
Last Updated:	April 25, 2013
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Keywords provided by Rijnstate Hospital:


Omeprazole, suppository, infants

Additional relevant MeSH terms:


Esophageal Atresia Gastroesophageal Reflux Hernia Hernia, Diaphragmatic Congenital Abnormalities Deglutition Disorders Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders	Gastrointestinal Diseases Pathological Conditions, Anatomical Omeprazole Anti-Ulcer Agents Enzyme Inhibitors Gastrointestinal Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Proton Pump Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015

To Top