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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:
Information provided by (Responsible Party):

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
Estimated Study Completion Date : December 2007


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Therapeutic efficacy

Secondary Outcome Measures :
  1. Intragastric pH, Pharmacokinetic parameters, PK-PD-relation,
  2. 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