Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants. - Full Text View

Sponsor:	Rijnstate Hospital
Collaborator:	Erasmus Medical Center
Information provided by:	Rijnstate Hospital
ClinicalTrials.gov Identifier:	NCT00226044

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 III

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

MedlinePlus related topics: Esophagus Disorders GERD Hernia

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

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

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

Study ID Numbers:	LTC-001
Study First Received:	September 22, 2005
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00226044 History of Changes
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Keywords provided by Rijnstate Hospital:

Omeprazole, suppository, infants

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Molecular Mechanisms of Pharmacological Action
Esophageal Atresia
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders

Deglutition Disorders
Digestive System Abnormalities
Digestive System Diseases
Therapeutic Uses
Hernia
Anti-Ulcer Agents
Hernia, Diaphragmatic
Esophageal Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 30, 2009