Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study.

Conditions
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Gastroesophageal Reflux, Esophageal Atresia, Hernia, Diaphragmatic

Intervention / Treatment
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* Drug: Omeprazole rectally 1mg/kg


Participation Criteria
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Eligibility Criteria
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Infants were eligible for the study if they were: 6-12 weeks postnatal age weighed more than 3 kg were after surgical repair for EA or CDH showed clinical GERD were to undergo the 48 hour pH measurements. Infants were excluded if they were: allergic to omeprazole participated in other interventional trials used medications known to interact with omeprazole.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study was an open-label randomized intervention trial to study the efficacy of a single oral or rectal administered omeprazole dose of 1 mg/kg in infants with GERD due to EA or CDH.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Oral omeprazole<br>Standard of care: A single dose of 1 mg/kg orally administered omeprazole. | |
| Active Comparator: Rectal omeprazole<br>A single dose of 1 mg/kg rectally administered omeprazole. | Drug: Omeprazole rectally 1mg/kg<br>* A single dose of 1 mg/kg rectally administered omeprazole.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic efficacy | Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH. | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intragastric pH | Secondary: outcomes were the percentage of time gastric pH was <3 and <4 | 24 hours | 
| Maximum plasma concentration (Cmax) | The maximal concentration of OME, OH-OME and OME-S in plasma (Cmax) | 8 hours | 
| Time to reach Cmax (Tmax) | time to reach Cmax (Tmax) | 8 hours | 
| Area under the curve (AUC) | The AUC from time zero to the last sampling time point (AUC0-t) | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omeprazole, suppository, infants