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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT02262169
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects aged 18-75 years old.
* Diagnosed as non-bleeding peptic ulcers who do not require endoscopic therapy, as confirmed by :
* The presence of endoscopically confirmed gastric or duodenal ulcer(s) at size(s) of at least 3 mm or larger.
* Subjects with low-risk of recurrent bleeding, defined as both:
* Complete Rockall score of ≤ 7.
* Endoscopic stigmata (lesion) of grade II-C or III based on Forrest classification.
* Able to take oral medication.
Exclusion Criteria:
* For females of childbearing potential: pregnancy, breast-feeding, the intention of becoming pregnant during the study participation.
* Patients must accept pregnancy tests during the trial if menstrual cycle is missed
* Fertile patients must use a reliable and effective contraceptive
* History of or known or suspected Zollinger Ellison syndrome.
* History of endoscopic therapy for bleeding ulcer within the past 4 weeks.
* Indication for endoscopic hemostasis therapy.
* Presence of Helicobacter pylori infection
* History of or known coronary artery disease (CAD), congestive heart failure, pulmonary disease, and any other uncontrolled chronic diseases.
* History of or known gastrointestinal malignancy or ulcers associated to malignancy.
* Currently known being afflicted by serious infection(s).
* Inadequate liver function
* Inadequate renal function
* Subjects being under therapy with any herbal medicines.
* Known hypersensitivity or idiosyncratic reaction or adverse drug reactions to proton pump inhibitors (PPIs).
* Participation in any other clinical studies within 30 days prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02262169
Study Brief:
Protocol Section:
NCT02262169