Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT00426595
Eligibility Criteria:
Inclusion Criteria:
* Children \> 15 kg
* Cerebral palsy and mental retardation with swallowing disorders
* Presence of gastrostomy tube
* GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks
* Informed consent
Exclusion Criteria:
* Treatment with ciclosporine, tacrolimus, mycofenolate
* Treatment with anticoagulants
* Infection
* Recent start of treatment with known inhibitors of the omeprazole-metabolism
* Moderate to severe hepatic impairment (SGPT and/or AST \> 3 times upper limit)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT00426595
Study Brief:
Protocol Section:
NCT00426595