Rectal and oral omeprazole treatment of gastroesophageal reflux in infants with esophageal atresia or congenital diaphragmatic hernia: A pharmacodynamic and pharmacokinetic study

Phase 2

Completed

• Conditions: Gastroesofageal reflux disease; GORD; 10017943

• Registration Number: NL-OMON38919
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Age ± 6 weeks and weight > 3 kg
Pathologic GERD, diagnosed by criteria stated in paragraph 2.3 --> pathologic GERD related to esophageal atresia or congenital hernia Diaphragmatica
Written Informed consent by both parents

Exclusion Criteria

Known hypersensitivity to omeprazole
Co-medication (or changes to prohibited comedication during the trial): alprazolam, midazolam, triazolam, carbamazepine, clorazepate, ciclosporine, disulfiram, fenytoïne, ferrous components, itraconazole, ketoconazole, voriconazole, methotrexate, tacrolimus, ticlopidine, warfarine
Patients with GERD caused by congentital malformations of the CNS

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of neonates in which treatment is effective based on gastic Ph and<br /><br>clinical findings</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>