Phase 2b Multi-center Clinical Trials to Clarify the Efficacy and Adaptation Target of DA9601 in Patients With Acute and Chronic Gastritis, and to Determine the Optimal Clinical Dosage and Administration.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Change in Subjective and Objective Symptoms, Gastroscopy, Overall Improvement, Effectiveness grade
研究概览
简要总结
This is a multicenter, placebo-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 2-week treatment with DA-9601 tab in patients with acute or chronic gastritis. Subject will receive DA-9601 180mg, 360mg tab or Placebo., three times a day for two weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with acute gastritis and chronic gastritis by endoscopy; have gastric mucosal lesions such as erosion, bleeding, redness, swelling on the site; and have subjective and objective symptoms requiring medical treatment ② 18 years old or older, 75 years old or younger ③ Patients who have agreed with the terms of clinical trials
排除标准
- •Patients with peptic ulcer (excluding scars) and reflux esophagitis
- •Patients who were administered with H2 antagonist, muscarine receptor antagonist or nonsteroidal anti-inflammatory drug within 2 weeks prior to the start of the trial
- •Patients using protective agent enhancers at the start of the trial ④ Patients with recurrence observed during maintenance therapy at the start of the trial
- •Patients with a history of gastrectomy
- •Patients with severe disorders of the liver, kidneys, heart, lungs, blood, etc. ⑦ Patients with duodenal ulcer ⑧ Patients with gastrointestinal malignancy
研究组 & 干预措施
Placebo
administered 2 tablets of placebo three times daily for two weeks
干预措施: Stillen® Tab Placebo (Drug)
DA-9601(Stillen®) 180mg
administered 1 tablet of placebo and 1 tablet of DA-9601(Stillen®) three times daily for two weeks
干预措施: Stillen® Tab (Drug)
DA-9601(Stillen®) 180mg
administered 1 tablet of placebo and 1 tablet of DA-9601(Stillen®) three times daily for two weeks
干预措施: Stillen® Tab Placebo (Drug)
DA-9601(Stillen®) 360mg
administered 2 tablets of DA-9601(Stillen®) three times daily for two weeks
干预措施: Stillen® Tab (Drug)
结局指标
主要结局
Change in Subjective and Objective Symptoms, Gastroscopy, Overall Improvement, Effectiveness grade
时间窗: 2 weeks
evaluated in 5 levels of "Significant improvement • Moderate improvement • Mild improvement • No improvement • Exacerbation"
次要结局
未报告次要终点