Effects of Ilaprazole 20mg on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone Endoscopic Submucosal Dissection(ESD) for Gastric Adenoma or Early Gastric Cancer.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- The Ulcer healing rate after endoscopic submucosal dissection
研究概览
简要总结
This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding.
详细描述
This study is a Multicenter, Randomized, Parallel and Prospective study to compare Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and to investigate Prevention of gastrointestinal bleeding.
Participants are defined as persons who underwent a Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer. For 8 weeks, Participants treated as Ilaprazole 20mg or Rabeprazole 20mg once a day. After treatment, The ulcer healing rate was evaluated by Endoscopy at 4, 8 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
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 year old ≤ Male or female < 85 year old
- •Subject who underwent Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer
- •Subject who agrees to participate and spontaneously sign the Informed consent form(ICF).
排除标准
- •Known hypersensitivity to any component of ilaprazole
- •Subjects who are taking contraindicated medications(ex. atazanavir) for experimental and concomitant drug.
- •Subjects with abnormal levels in the laboratory tests
- •Total Bilirubin, Creatinine> 1.5 times upper limit of normal
- •Alanine transaminase(ALT), Aspartate transaminase(AST), Alkaline phosphatase, Blood urea nitrogen(BUN)> 2 times upper limit of normal
- •Subjects diagnosed with other cancer within 5 years other than stomach cancer.
- •Subjects with a history of Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal strictures, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease
- •Subjects with a history of major surgery that can affect gastric acid secretion.
- •Subjects should continue taking the following medicine during the study period : anticholinergics, promoting motility agents, prostaglandin analogs, sucralfate, aspirin, steroid, NSAIDs drug
- •Subjects with uncontrolled organ failure (liver dysfunction, renal dysfunction)
- •Pregnant and/or lactating women
- •Subjects participating in a clinical trial before another trial within 30 days
- •Inconsistency judged subject by researcher
研究组 & 干预措施
Ilaprazole
Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks.
干预措施: Ilaprazole (Drug)
Rabeprazole
Rabeprazole tab 20mg, 1 tablet once daily for 8 weeks.
干预措施: Rabeprazole (Drug)
结局指标
主要结局
The Ulcer healing rate after endoscopic submucosal dissection
时间窗: participants will be followed at 8 weeks
次要结局
- The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy.(at 8 weeks after treatment)
- The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire.(at 8 weeks after treatment)
- The rate of Ulcer size reduction as assessed by measurements of ulcer size change.(at 8 weeks after treatment)