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:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT02835560
Eligibility Criteria:
Inclusion Criteria:
* Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
* Subject who fully understands conditions of clinical trial.
* Subject who agrees to participate and spontaneously sign the ICF.
Exclusion Criteria:
* Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin.
* Subjects who are taking contraindicated medications for experimental and concomitant drug.
* Patients with abnormal levels in the laboratory tests.
* Total Bilirubin, Creatinine\> 1.5 times upper limit of normal.
* AST, ALT, Alkaline phosphatase, BUN\> 2 times upper limit of normal.
* Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study.
* Pregnant and/or lactating women.
* Reproductive aged women not using contraception.
* Uncontrolled diabetics.
* Uncontrolled hypertension.
* Uncontrolled liver dysfunction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02835560
Study Brief:
Protocol Section:
NCT02835560