A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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