NCT05163756已完成3 期
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients With Gastritis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- The efficacy rate on gastroscopy
研究概览
简要总结
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients with 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)
盲法说明
Double (Participant, Investigator) Double-blind
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
- •Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial.
- •At least one or more erosions have been identified on gastroscopy.
- •Patients who decided to voluntarily participate in this trial and agreed in writing.
排除标准
- •Patients who can not undergo gastroscopy
- •Peptic ulcer (except scarring) and reflux esophagitis
- •Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy)
- •Patients with a history of gastrointestinal malignancies
- •Zollinger-Ellison syndrome patients
- •Patient with spontaneous coagulation disorder
- •Patients with an allergic or hypersensitive response to a study drug
- •Patients with a potential pregnancy.
- •Patients who had clinically significant abnormalities in the screening test.
- •Pregnant and lactating women
- •Those currently taking other study drugs
- •patients who were judged to be ineligible for the trial by the principle investigator and the person in charge.
研究组 & 干预措施
DW1903(Test)
Experimental
once a day, q.d. PO / DW1903 + Placebo of DW1903-R1
干预措施: DW1903 (Drug)
DW1903-R1(Reference)
Active Comparator
once a day, q.d. PO / Placebo of DW1903 + DW1903-R1
干预措施: DW1903-R1 (Drug)
结局指标
主要结局
The efficacy rate on gastroscopy
时间窗: Week 0, Week2
The efficacy rate is obtained from the following formula using the subject whose erroneous score is improved by 50% or more as compared with before the study drug administration. The efficacy rate(%) = (number of effective cases)/(all cases) x 100 Effective case is determined by the grade change of erosion. A case in which the grade changes from 4 to 2 or 1, from 3 to 1, or from 2 to 1 is judged as an effective case.
次要结局
- Cure rate on gastroscopy(Week 0, Week2)
研究者
研究点 (1)
Loading locations...
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