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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

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