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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT00148603
Eligibility Criteria:
Inclusion Criteria:
A subject will be eligible for inclusion in this study if all of the following criteria are met:
* Patients with dyspepsia defined as upper abdominal pain or discomfort of at least two months duration.
* Male and female subjects 6 - 17 years of age
* Endoscopic mucosal biopsies revealing at least 20 eosinophils in a high power field on specimens from the duodenum in the absence of other defined duodenal pathology.
* Written informed consent signed by the subject's legal guardian and by the investigator and patient assent.
Exclusion Criteria:
Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
* A subject who has previously been treated with montelukast.
* Treatment with steroids or oral cromolyn in the four weeks prior to endoscopy or during the study.
* Any history, clinical, and/or biochemical evidence of clinically significant renal or liver disease.
* Treatment with any inducers or inhibitors of CYP3A4.
* Intake of grapefruit juice or oral vitamin E supplementation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT00148603
Study Brief:
Protocol Section:
NCT00148603