NCT02342470已完成2 期
A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled, Dose-finding, Phase IIa Clinical Trial to Efficacy and Safety of PMK-S005 for the Prevention of Recurrent Peptic Ulcer in Low-dose Aspirin Users
PharmaKing1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2014年11月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The incidence of endoscopic peptic ulcer
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety by comparing prevention of recurrent peptic ulcer in low-dose aspirin users between PMK-S005 and Placebo.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 19 years of age
- •Accompanied by hypertension, diabetes, ischemic heart disease, arrhythmia, dyslipidemia patients who are required to continuous administration of low-dose aspirin(100mg)
- •Patients who get Modified Lanza Score (MLS) 0 in screening period according to endoscopic findings
- •Patients who have stomach or duodenal ulcer scar in screening period according to endoscopic findings. But, the cases that scars caused by other disorders or endoscopic treatment are excluded
- •Patients who have no digestive symptoms(except for mild physconia, abdominal pain, diarrhea and vomit, nausea-vomiting) in screening period
- •Signature of the written informed consent
排除标准
- •Within 4 weeks prior to screening period, patients who continuously take aspirin or NSAIDs
- •Patient who has hypersensitivity to PMK-S005 and aspirin components or is banned to use them
- •Patients who had a abdominal surgery that affect gastrointestinal motility (Except appendectomy and hysterectomy), But, patients who had enterectomy is excluded regardless of the time period
- •Patients who are judged by investigator that they have other upper gastroesophageal disease, active/healing-stage peptic ulcer, digestive malignant tumor or Barrett's esophagus
- •Patients with Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's disease, Zolinger-Ellison syndrome
- •History of esophagus, liver, pancreas, stomach, colorectal cancer or malignant tumors within 5 years
- •History of malabsorption within 3 months prior to screening period
- •Patients who have been taken drug that affect the validity within 2 weeks before beginning of the clinical test
- •Patient who is needed continuously to take antithrombotic agents , anti- coagulant , anti- choline agents, prostaglandins , mucosal protective agents , methotrexate, antidepressants , iron treat agents during clinical test.
- •Patients with clinical meaningful laboratory test results
- •Known alcohol and/or any other drug abuse or dependence
- •Pregnant or lactating women
- •Women planning to become pregnant
- •Within 1 month, patients who have been taken other clinical test drug
- •Patients who are judged by investigator that participation of the study is difficult
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo Comparator / Bid
干预措施: Placebo (Drug)
PMK-S005 1
Experimental
Total 50mg, by mouth, bid
干预措施: PMK-S005 1 (Drug)
PMK-S005 2
Experimental
Total 100mg, by mouth, bid
干预措施: PMK-S005 2 (Drug)
PMK-S005 3
Experimental
Total 150mg, by mouth, bid
干预措施: PMK-S005 3 (Drug)
结局指标
主要结局
The incidence of endoscopic peptic ulcer
时间窗: 12 weeks
次要结局
- The changes of MLS in the gastroduodenal endoscopy result compared to baseline(12 weeks)
- The incidence of endoscopic esophagitis(16 weeks)
- Rescue drug use count and the total amount(16 weeks)
- Changes in gastrointestinal symptoms score(16 weeks)
- The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer)(12 weeks)
- The incidence of endoscopic stomach / duodenal ulcer(12 weeks)
- The incidence of endoscopic stomach / duodenal erosion(12 weeks)
研究者
研究点 (1)
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