NCT04341454已完成3 期
A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 327 人开始时间: 2020年6月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Improvement rate of gastric mucosal erosion
研究概览
简要总结
The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis
详细描述
This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 19 and 75 years old based on the date of written agreement
- •Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy
- •Those who had experienced one or more subjective symptoms of gastritis
排除标准
- •Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery
- •Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results
研究组 & 干预措施
DWP14012 X mg QD
Experimental
- Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo
- Evening: 1 tablet of DWP14012 Y mg placebo
干预措施: DWP14012 X mg (Drug)
DWP14012 X mg QD
Experimental
- Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo
- Evening: 1 tablet of DWP14012 Y mg placebo
干预措施: DWP14012 Y mg placebo (Drug)
DWP14012 Y mg BID
Experimental
- Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg
- Evening: 1 tablet of DWP14012 Y mg
干预措施: DWP14012 X mg placebo (Drug)
DWP14012 Y mg BID
Experimental
- Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg
- Evening: 1 tablet of DWP14012 Y mg
干预措施: DWP14012 Y mg (Drug)
placebo
Placebo Comparator
- Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo
- Evening: 1 tablet of DWP14012 Y mg placebo
干预措施: DWP14012 X mg placebo (Drug)
placebo
Placebo Comparator
- Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo
- Evening: 1 tablet of DWP14012 Y mg placebo
干预措施: DWP14012 Y mg placebo (Drug)
结局指标
主要结局
Improvement rate of gastric mucosal erosion
时间窗: at 2 weeks after the IP administration
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100
次要结局
- Cure rate of gastric mucosal erosion(at 2 weeks after the IP administration)
- Cure rate of gastric mucosal edema(at 2 weeks after the IP administration)
- Improvement rate of gastric mucosal erythema(at 2 weeks after the IP administration)
- Improvement rate of gastric mucosal bleeding(at 2 weeks after the IP administration)
- Improvement rate of subjective symptoms(at 2 weeks after the IP administration)
研究者
研究点 (1)
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