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

Tracking Information

First Received Date ^ICMJE

September 22, 2005

Last Updated Date

March 28, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Therapeutic efficacy

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00226044 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Official Title ^ICMJE

Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study.

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Gastroesophageal Reflux
Esophageal Atresia
Hernia, Diaphragmatic

Intervention ^ICMJE

Drug: Omeprazole suppository

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

6 Weeks to 3 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: P. Bestebreurtje, Pharm D

+31355391398

pbestebreurtje@tergooiziekenhuizen.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00226044

Responsible Party

Study ID Numbers ^ICMJE

LTC-001

Study Sponsor ^ICMJE

Rijnstate Hospital

Collaborators ^ICMJE

Erasmus Medical Center

Investigators ^ICMJE

Study Director:

D. Tibboel, Prof. Dr.

Erasmus Medical Center

Information Provided By

Rijnstate Hospital

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP