Clinical trial NCT00226044: Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Esophageal Atresia
Hernia, Diaphragmatic
Keywords: Omeprazole, suppository, infants
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2005-09-26
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic efficacy
timeFrame: 24 hour
Secondary outcomes:
measure: Intragastric pH
timeFrame: 24 hours
measure: Maximum plasma concentration (Cmax)
timeFrame: 8 hours
measure: Time to reach Cmax (Tmax)
timeFrame: 8 hours
measure: Area under the curve (AUC)
timeFrame: 8 hours
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical center
Study officials:
affiliation: Erasmus Medical Center
name: S.N. de Wildt, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Bestebreurtje P, de Koning BAE, Roeleveld N, Knibbe CAJ, Tibboel D, van Groen B, van de Ven CP, Plotz FB, de Wildt SN. Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial. Eur J Drug Metab Pharmacokinet. 2020 Oct;45(5):635-643. doi: 10.1007/s13318-020-00630-8.