Text Size

Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

This study is currently recruiting participants.
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:

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

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

ClinicalTrials.gov processed this record on May 19, 2013