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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT02648659
Eligibility Criteria:
Inclusion Criteria:
* • 20 year old ≤ Male or female \< 80 year old
* Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody test.
* Subject who fully understands conditions of clinical trial
* Subject who agrees to participate and spontaneously sign the ICF
Exclusion Criteria:
* Known hypersensitivity to experimental and concomitant drugs
* Subjects who are taking contraindicated medications for experimental and concomitant drug.
* Subjects 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 2 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
* Alcoholics
* Subjects with a history or possibility of digestive malignancy within 5 years
* Subjects with a history of gastrectomy or esophagectomy
* Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
* Subjects participating in a clinical trial before another trial within 30 days
* Inconsistence judged subject by researcher
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT02648659
Study Brief:
Protocol Section:
NCT02648659