Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Study Description

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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

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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

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Therapeutic efficacy

Secondary Outcome Measures :

1. Intragastric pH, Pharmacokinetic parameters, PK-PD-relation,
2. Pharmacogenetic parameters

Eligibility Criteria

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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

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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

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Responsible Party:	Rijnstate Hospital
ClinicalTrials.gov Identifier:	NCT00226044 History of Changes
Other Study ID Numbers:	LTC-001
First Posted:	September 26, 2005
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