A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of HIP0612 in Patients With Gastric Ulcer

HM-AESOP-301

A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.

2023-01-01

2023-12-01

2023-12-01

Not yet recruiting

Early phase I

226

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 226, 'type': 'ESTIMATED'}}

2022-12-22