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

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

Official Title
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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

Conditions
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Gastritis

Intervention / Treatment
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* Drug: HIP2101
* Drug: RLD2101
* Drug: HPP2101
* Drug: HPP2102


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIP2101<br>Taking HIP2101+HPP2102 once daily for 2 weeks. | Drug: HIP2101<br>* Test drug<br>Drug: HPP2102<br>* Placebo drug<br>|
| Active Comparator: RLD2101<br>Taking RLD21012101+HPP2101 once daily for 2 weeks. | Drug: RLD2101<br>* Reference drug<br>Drug: HPP2101<br>* Placebo drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rate of erosion | percentage of subjects whose erosion score is improved by more than 50% | week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate of erosion | percentage of subjects whose erosion is completely cured | week 2 | 
| Cure rate of edema | percentage of subjects whose edema is completely cured | week 2 | 
| Improvement rate of erythema | percentage of subjects whose erythema score is improved by more than 50% | week 2 | 
| Improvement rate of hemorrage | percentage of subjects whose hemorrage score is improved by more than 50% | week 2 | 
| Improvement rate of GI symptoms | percentage of subjects whose GI symptoms score is improved by more than 50% | week 2 |