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| Sponsors and Collaborators: |
Rijnstate Hospital Erasmus Medical Center |
|---|---|
| Information provided by: | Rijnstate Hospital |
| ClinicalTrials.gov Identifier: | NCT00226044 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study. |
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | December 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: P. Bestebreurtje, Pharm D | +31355391398 | pbestebreurtje@tergooiziekenhuizen.nl |
| 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 | |
| Study Director: | D. Tibboel, Prof. Dr. | Erasmus Medical Center |
More Information
| Study ID Numbers: | LTC-001 |
| Study First Received: | September 22, 2005 |
| Last Updated: | March 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00226044 History of Changes |
| Health Authority: | Netherlands: Dutch Health Care Inspectorate |
|
Omeprazole, suppository, infants |
|
Pathological Conditions, Anatomical Esophageal Atresia Gastrointestinal Diseases Omeprazole Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Digestive System Abnormalities |
Digestive System Diseases Congenital Diaphragmatic Hernia Esophageal Disorder Hernia Hernia, Diaphragmatic Esophageal Diseases Congenital Abnormalities |
|
Pathological Conditions, Anatomical Molecular Mechanisms of Pharmacological Action Esophageal Atresia Gastrointestinal Diseases Gastrointestinal Agents Omeprazole Enzyme Inhibitors Gastroesophageal Reflux Pharmacologic Actions Esophageal Motility Disorders |
Deglutition Disorders Digestive System Abnormalities Digestive System Diseases Therapeutic Uses Hernia Anti-Ulcer Agents Hernia, Diaphragmatic Esophageal Diseases Congenital Abnormalities |
