NCT05072938已完成4 期
A Multi-center, Open-label, Randomized, Phase IV Clinical Trial to Compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2021年9月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy
研究概览
简要总结
The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis
详细描述
The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis.
Anticipated result is to prove superiority of Rebamipide/Nizatidine combination therapy at 2 weeks compared to Nizatidine Monotherapy.
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
- None
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 19 years or older and under 75 years
- •Subject who was diagnosed with acute or chronic gastritis in upper gastrointestinal endoscopy conducted within 7 days prior to the start of administration of medications for clinical trials and identified at least one labyrinth (defect of mucosal surface layer)
- •Subject who voluntarily decides to participate in the trial after hearing the explanation of this clinical trial and signs the informed consent form.
- •Exclusion Criteria
- •Subject who is unable to examine the upper gastrointestinal endoscope
- •A person with the following past history
- •Surgery to suppress gastric acid secretion or gastrointestinal and esophagus surgery
- •Malignant tumor of the digestive system
- •overreacted to the components of medicine for clinical trials and H2 receptor blockers
- •Drug or alcohol abuse
- •A person accompanied by the following diseases
- •Digestive ulcers (excluding half a scar)
- •Reflux esophagitis
- •Inflammatory bowel disease (cron disease, ulcerative colitis)
- •Thrombotic diseases (such as cerebral thrombosis, myocardial infarction, thrombotic venous inflammation, etc.)
- •Zollinger-Ellison syndrome
- •Subject with mental illness, cardiovascular system, respiratory system, endocrine system, central nervous system who the investigator determined that it is difficult to participate in this clinical trial
- •A person who needs to administer a taboo drug during the clinical trial period.
- •Pregnant women and nursing women
- •Fertilized women and men who have a pregnancy plan or do not have the will to use the appropriate contraceptive method during the clinical trial period.
- •Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- •Severe liver disorder (AST or ALT > 3 times the normal upper limit of the organ)
- •Serious nephropathy (creatinine clearance < 50 mL/min)
- •Subject who has been administered (applied) other clinical medications or medical devices within 4 weeks of screening
- •Subject who the investigator determined it is inappropriate to participate in this clinical trial.
排除标准
- 未提供
研究组 & 干预措施
Nizatidine Monotherapy
Active Comparator
Nizatidine Monotherapy
干预措施: Axid Capsule 150mg (Drug)
Rebamipide/Nizatidine Combination Therapy
Experimental
Rebamipide/Nizatidine Combination Therapy
干预措施: Mucotra SR Tablet 150mg (Drug)
结局指标
主要结局
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy
时间窗: 2 weeks
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy at 2 weeks compated to baseline
次要结局
- Effective rate of flares on upper gastrointestinal endoscopy(2 weeks)
- Validity rate of subjective symptom scores evaluated by subjects(2 weeks)
- Erosion cure rate on upper gastrointestinal endoscopy(2 weeks)
- Effective rate of bleeding on upper gastrointestinal endoscopy(2 weeks)
- Edema cure rate on upper gastrointestinal endoscopy(2 weeks)
- Change in total subjective symptom score and individual symptom score assessed by the subject at 2 weeks compared to baseline(2 weeks)
研究者
研究点 (1)
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