Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Rijnstate Hospital

Status and phase: Completed; Phase 3

Conditions: Esophageal Atresia; Gastroesophageal Reflux; Hernia, Diaphragmatic

Treatments: Drug: Omeprazole rectally 1mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT00226044

LTC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 6 weeks to 3 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

Oral omeprazole

No Intervention group

Description:

Standard of care: A single dose of 1 mg/kg orally administered omeprazole.

Rectal omeprazole

Active Comparator group

Description:

A single dose of 1 mg/kg rectally administered omeprazole.

Treatment:

Drug: Omeprazole rectally 1mg/kg