Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

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ClinicalTrials.gov Identifier: NCT00226044

Recruitment Status : Unknown

Verified April 2013 by Rijnstate Hospital.
Recruitment status was: Recruiting

First Posted : September 26, 2005

Last Update Posted : April 26, 2013

Sponsor:

Collaborator:

Erasmus Medical Center

Information provided by (Responsible Party):

Rijnstate Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastroesophageal Reflux Esophageal Atresia Hernia, Diaphragmatic	Drug: Omeprazole suppository	Phase 3

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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.
Study Start Date :	September 2005
Study Completion Date :	December 2007

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Therapeutic efficacy

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	6 Weeks to 3 Months (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


Responsible Party:	Rijnstate Hospital
ClinicalTrials.gov Identifier:	NCT00226044 History of Changes
Other Study ID Numbers:	LTC-001
First Posted:	September 26, 2005 Key Record Dates
Last Update Posted:	April 26, 2013
Last Verified:	April 2013

Keywords provided by Rijnstate Hospital:


Omeprazole, suppository, infants

Additional relevant MeSH terms:


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

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