Adminstration of omeprazole by rectiole or oral tablet for the treatment of reflux disease in neonates and infants with a closure of the esophagus or a congenital opening in the diaphragm.
- Conditions
- GORD,Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-002026-22-NL
- Lead Sponsor
- ErasmusMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method