A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.
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
Locations (1)
Asan Medical Center
Seoul, South Korea
Outcomes
Primary Outcomes
Healing rate of gastric ulcer
Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study
Time frame: week 8
Secondary Outcomes
Healing rate of gastric ulcer
Time frame: week 4
Healing rate of gastric ulcer according to H.pylori infection status