Double Blind, Multicenter, Randomized, Placebo-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
Overview
- Phase
- Phase 2
- Intervention
- GC6101A 37.5mg
- Conditions
- Gastritis
- Sponsor
- Green Cross Corporation
- Enrollment
- 200
- Locations
- 14
- Primary Endpoint
- A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
GC6101A 37.5mg
Administer 12.5mg of GC6101A t.i.d for 2 weeks.
Intervention: GC6101A 37.5mg
GC6101A 75mg
Administer 25mg of GC6101A t.i.d for 2 weeks.
Intervention: GC6101A 75mg
GC6101A 150mg
Administer 50mg of GC6101A t.i.d for 2 weeks.
Intervention: GC6101A 150mg
Placebo
Administer placebo t.i.d for 2 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy
Time Frame: 2 weeks
The definition of "moderate improvement" is the subjects showed score changed from 2-4 to 1 or from 4 to 2. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\]
Secondary Outcomes
- Adverse Events(2 weeks)
- Lab results(Hematology, Blood chemistry, Urinalysis)(2 weeks)
- A percentage of subjects showed significant improvement of stomach erosions by the endoscopy(2 weeks)
- A percentage of subjects showed improvement of edema rating scale(2 weeks)
- A percentage of subjects showed improvement of erythema rating scale(2 weeks)
- A percentage of subjects showed improvement of hemorrhage rating scale(2 weeks)
- A percentage of subjects showed improvement of gastric symptom rating scale(2 weeks)
- The results of physical examinations and Vital signs(body temperature, pulse)(2 weeks)
- EKG results(2 weeks)