A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5204 and to Demonstrate the Non-inferiority of DA-5204 Compared With Stillen Tab. in Patients With Acute or Chronic Gastritis
试验速览
- 阶段
- 3 期
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.
研究概览
简要总结
This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is over 20 years old, under 75 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 administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
- •Patients with surgery related to gastroesophageal
- •Patients with Zollinger-Ellison syndrome
- •Patients with any kind of malignant tumor
- •Patients administered with anti-thrombotic drugs
- •Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
- •Patients with neuropsychiatric disorder, alcoholism, or drug abuse
- •Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.
- •Women either pregnant or breast feeding
研究组 & 干预措施
DA-5204
DA-5204 administered two times daily for two weeks
干预措施: DA-5204 (Drug)
Stillen tab.
Stillen tab. administered three times daily for two weeks
干预措施: Stillen tab. (Drug)
结局指标
主要结局
A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.
时间窗: 2 weeks
The definition of "moderate improvement" is the subjects showed score changed from 4 to 1 or from 2 to 1. And, "significant improvement" means the subject showed score changed from 4 to 1 or from 3 to 1. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\]
次要结局
- A percentage of completely cured subject after a treatment(2 weeks)
- A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale.(2 weeks)