Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis

A Multicenter, Randomized, Double-blind, Active-controlled, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis

The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis.

Inclusion Criteria:

• 19≤ age ≤ 75
• Have been diagnosed as acute or chronic gastritis with at least 1 erosion by endoscopy within 7 days before enrollment.
• Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

• Patients who cannot perform endoscopy
• Active gastric or duodenal ulcer
• Reflux esophagitis, barrett's esophagus, gastric or esophageal varix
• Zollinger-Ellison syndrome, pyloric obstruction, and esophageal stricture, Inflammatory Bowel Diease, acute pancreatitis
• History of gastrointestinal surgery
• History of malignancy tumor, especially in the upper gastrointestinal tract
• Severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
• Severe renal disorder(at screening day, MDRD eGFP ≤ 30 mL/min/1.73m2) or chronic renal disease
• Bleeding disorder
• Patients who have taken drugs containing following list within 2 weeks before endoscopy : H2-receptor antagonists, Proton pump inhibitors, P-CABs, gastrin inhibitors, antacids, gastric mucosal protectants, anticholinergics
• Patients who have taken anticoagulants within a week before endoscopy
• Patients who have taken drugs containing following list after endoscopy : GI tract regulators, salicylates, steroids, , NSAIDs, bisphosphonates, selective serotonin reuptake inhibitors, iron supplements, oriental herbal medicines
• History of allergic reaction to the medications used in this study
• 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