Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226044
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2005-09-22
Brief Title:
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia A Pharmacodynamic and Pharmacokinetic Study
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 03 - 35 mgkgday
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 formThis 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
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 formThis 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None