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
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Esophageal Atresia Hernia, Diaphragmatic||Drug: Omeprazole suppository||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Completion Date :||December 2007|
- Therapeutic efficacy
- Intragastric pH, Pharmacokinetic parameters, PK-PD-relation,
- Pharmacogenetic parameters
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
|Contact: P. Bestebreurtje, Pharm Dfirstname.lastname@example.org|
|Erasmus Medical center||Recruiting|
|Rotterdam, Netherlands, 3015 GD|
|Contact: D. Tibboel, Prof. dr.|
|Contact: P. Bestebreurtje, Pharm D +31263786300 email@example.com|
|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|