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Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Rijnstate Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00226044
First Posted: September 26, 2005
Last Update Posted: April 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
Rijnstate Hospital
  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
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.

Resource links provided by NLM:


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

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 Submitted: September 22, 2005
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