A Phase IV Clinical Trial to Evaluate the Preventive Effectiveness of NSAID-Associated Gastroduodenal Injury (Multi-center, Double-blind, Active-controlled, Stratified Randomized, Parallel Group)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- the percentage of protected subjects (%)
研究概览
简要总结
This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.
详细描述
After filling an Informed consent form, subjects are joined the clinical trials. First of all, Screening test including the endoscopy test is performed.
Subjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes investigation products as randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Need to take NSAID pills for longer than four weeks
- •should be normal diagnosed by the endoscopy test
排除标准
- •The patients have gastric ulcer or duodenal ulcer within 30 days
- •The patients have a gastro-intestinal surgery within a year
- •The patients are taking the following drugs within seven days: H2 receptor antagonist, PPI, sucralfate, misoprostol, Stillen etc)
研究组 & 干预措施
Stillen
Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID
干预措施: Stillen (Drug)
Stillen
Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID
干预措施: NSAID (Aceclofenac) (Drug)
Cytotec
The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID
干预措施: Cytotec (reference drug) (Drug)
Cytotec
The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID
干预措施: NSAID (Aceclofenac) (Drug)
结局指标
主要结局
the percentage of protected subjects (%)
时间窗: 4 weeks
the definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at stomach by the endoscopy.
次要结局
- A percentage of a protected subject (at duodenum), and of ulcer occurrence(4 weeks)