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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT02084420
Eligibility Criteria:
Inclusion Criteria:
* 18 year old ≤ Male or female \< 75 year old
* Patients who had endoscopically confirmed Gastric and/or duodenal ulcer and H.pylori infection confirmed by Urea Breath Test
* Patients who understand the study conditions
* Patients who had been given the explanation about the study, and had provided voluntary written informed consent to participate in the stud
Exclusion Criteria:
* Patients with known allergy or hypersensitivity reaction to the Investigational products
* Patients who use the Investigational products
* Patients who undergone H.pylori eradication
* Patients with abnormal laboratory results, as specified below:
Total bilirubin, creatinine \> 1.5 x upper limit of normal Aspartate transminase, Alanine transminase, Alkaline phosphatase, Blood urea nitrogen \> 2 x upper limit of normal
* Patients who used Proton Pump Inhibitor agents or antibiotics within the last 2 weeks before the start of the Investigational products
* Pregnant women and lactating women
* Women of childbearing potential who were not using a medically acceptable method of contraception during the study period.(Menopausal women who did not have a menstrual period for at least 12 months were considered infertile)
* Patients with uncontrolled Diabetes mellitus
* Patients with uncontrolled Hypertension
* Patients with Alcoholics
* Patients with a history of malignancy within 5 years prior to the study entry (Day 1) (except for basal cell carcinoma of the skin)
* Patients who had undergone a esophageal or gastric surgery
* Patients who had a hereditary disorder as galactose intolerance, lactose intolerance, glucose-galactose malabsorption
* Patients who had participated in other investigational study within 30 days before the study entry (Day 1)
* Patients who, in the investigator's opinion, are not suitable for the study for any other reason
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT02084420
Study Brief:
Protocol Section:
NCT02084420