Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226044
• Other study ID #: LTC-001
• Status: Completed
• Phase: Phase 3
• Start date: September 2005
• Est. completion date: September 2017

Study information

• Verified date: October 2019
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Weeks to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Atresia
• Gastroesophageal Reflux
• Hernia
• Hernia, Diaphragmatic

Intervention

Drug:
• Omeprazole rectally 1mg/kg
A single dose of 1 mg/kg rectally administered omeprazole.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic efficacy	Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.	24 hour
Secondary	Intragastric pH	Secondary: outcomes were the percentage of time gastric pH was <3 and <4	24 hours
Secondary	Maximum plasma concentration (Cmax)	The maximal concentration of OME, OH-OME and OME-S in plasma (Cmax)	8 hours
Secondary	Time to reach Cmax (Tmax)	time to reach Cmax (Tmax)	8 hours
Secondary	Area under the curve (AUC)	The AUC from time zero to the last sampling time point (AUC0-t)	8 hours