Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Phase 3

Completed

• Conditions: Esophageal Atresia; Gastroesophageal Reflux; Hernia, Diaphragmatic
• Interventions: Drug: Omeprazole rectally 1mg/kg

• Registration Number: NCT00226044
• Lead Sponsor: Rijnstate Hospital

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 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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-09-22
• Study First Posted: 2005-09-26
• Primary Completion: 2016-09
• Study Completion: 2017-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectal omeprazole	Omeprazole rectally 1mg/kg	A single dose of 1 mg/kg rectally administered omeprazole.

Primary Outcome Measures

Name	Time	Method
Therapeutic efficacy	24 hour	Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erasmus Medical center; 🇳🇱 Rotterdam, Netherlands