Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of the investigational products in the patients with gastritis during their participation in the study.

Detailed Description
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GC6101A is botanical drug products made from the Lonicerae Flos. Two hundred volunteers will participate in the study, receive 2-week treatment with GC6101A or placebo.

Official Title
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Double Blind, Multicenter, Randomized, Placebo-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis

Conditions
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Gastritis

Intervention / Treatment
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* Drug: GC6101A 37.5mg
* Drug: GC6101A 75mg
* Drug: GC6101A 150mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is over 19 years old, men or women Patients diagnosed with acute or chronic gastritis by gastroscopy Patients with one or more erosions found by gastroscopy Signed the informed consent forms Exclusion Criteria: Patients who is impossible to receive gastroscopy Patients with peptic ulcer and gastroesophageal reflux disease Patients with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy) Patients with esophageal varix Patients with malignant neoplasm of gastrointestinal tract Patients with thrombosis or administered with anti-thrombotic drugs Patients with consumption coagulopathy Patients administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 2 weeks Patient who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment Allergic or hypersensitive to any of the ingredients in the test products Pregnant or lactating female Patients who have abnormal baseline laboratory test result Patients taking other investigational drugs within 30 days prior to the study. Patients with Zollinger-Ellison syndrome Patients that investigators consider ineligible for this study

Ages Eligible for Study
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Minimum Age: 19 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC6101A 37.5mg<br>Administer 12.5mg of GC6101A t.i.d for 2 weeks. | Drug: GC6101A 37.5mg<br>* Administer 12.5mg of GC6101A t.i.d for 2 weeks.<br>|
| Experimental: GC6101A 75mg<br>Administer 25mg of GC6101A t.i.d for 2 weeks. | Drug: GC6101A 75mg<br>* Administer 25mg of GC6101A t.i.d for 2 weeks.<br>|
| Experimental: GC6101A 150mg<br>Administer 50mg of GC6101A t.i.d for 2 weeks. | Drug: GC6101A 150mg<br>* Administer 50mg of GC6101A t.i.d for 2 weeks.<br>|
| Placebo Comparator: Placebo<br>Administer placebo t.i.d for 2 weeks. | Drug: Placebo<br>* Administer placebo t.i.d for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy | The definition of moderate improvement is the subjects showed score changed from 2-4 to 1 or from 4 to 2. [score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions] | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A percentage of subjects showed significant improvement of stomach erosions by the endoscopy | The definition of significant improvement is the subject showed score changed from 2-4 to 1. [score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions] | 2 weeks | 
| A percentage of subjects showed improvement of edema rating scale | The definition of improvement is the subjects showed score changed from 2 to 1. | 2 weeks | 
| A percentage of subjects showed improvement of erythema rating scale | The definition of improvement is the subjects showed reduction ratio of score changed 50% or more. | 2 weeks | 
| A percentage of subjects showed improvement of hemorrhage rating scale | The definition of improvement is the subjects showed reduction ratio of score changed 50% or more. | 2 weeks | 
| A percentage of subjects showed improvement of gastric symptom rating scale | The definition of improvement is the subjects showed reduction ratio of score changed 50% or more. | 2 weeks | 
| Adverse Events |  | 2 weeks | 
| Lab results(Hematology, Blood chemistry, Urinalysis) |  | 2 weeks | 
| The results of physical examinations and Vital signs(body temperature, pulse) |  | 2 weeks | 
| EKG results |  | 2 weeks |