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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT05656092
Eligibility Criteria:
Inclusion Criteria:
* 19 years to 75 years
* Diagnosis of active gastric ulcers according to the Sakita-Miwa classification from upper GI endoscopy
* Patients understood the consents and purpose of this trial and signed consent form
Exclusion Criteria:
* Patients who cannot perform endoscopy
* Finding of malignancy, duodenal ulcer, ulcer perforation, postoperative (eg, endoscopic mucosal resection, endoscopic submucosal dissection) ulcer(s), Barrett's oesophagus measuring \>3cm, oesophageal dysplasia, oesophageal and/or gastric varices, bleeding disorder on upper GI endoscopy
* History of definitive acid lowering surgery or pervious oesophageal or gastric surgery (except for benign tumor excisionn, simple close of perforations)
* Zollinger-Ellison syndrome, pyloric stenosis, oesophageal motility disorder, esophageal stricture
* Severe hepatic disease
* Severe renal disease, CKD
* Bleeding disorder
* History of malignancy or was treated for malignancy within 5 years before the start of the Visit 1
* Patients who have taken drugs containing following list within 2 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: acid suppressive drugs, antacids, anticholinergic drugs, gastroprotective agent
* Patients who have taken drugs containing following list within 1 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: antithrombotic agents, NSAIDs, aspirin
* Requirement of use of excluded medications during the study
* History of allergic reaction to the medications used in this study
* Glucose-galactose malabsorption, Fructose intolerance, Sucrase-isomaltase deficiency
* Use of other investigational drugs within 30 days prior to the study
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with other reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT05656092
Study Brief:
Protocol Section:
NCT05656092