Double Blind, Multicenter, Randomized, Placebo-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GC6101A 37.5mg
Administer 12.5mg of GC6101A t.i.d for 2 weeks.
干预措施: GC6101A 37.5mg (Drug)
GC6101A 75mg
Administer 25mg of GC6101A t.i.d for 2 weeks.
干预措施: GC6101A 75mg (Drug)
GC6101A 150mg
Administer 50mg of GC6101A t.i.d for 2 weeks.
干预措施: GC6101A 150mg (Drug)
Placebo
Administer placebo t.i.d for 2 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy
时间窗: 2 weeks
The definition of "moderate improvement" is the subjects showed score changed from 2-4 to 1 or from 4 to 2. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\]
次要结局
- 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)