Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid: A Single-center, Randomized, Open Labeled, Pilot Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 主要终点
- Percentage of patients with gastric damage
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of eupatilin on the prevention of gastroenteropathy in patients with NSAIDs and low dose steroid by comparing with rebamipide.
详细描述
After being informed of the study and potential risks, all patients giving written informed consents will undergo a 1-week screening period to determine eligibility for study entry. During screening period, patients will undergo fecal calprotectin test, upper endoscopy and submit symptom diary. At week 0, subjects who meet the eligibility criteria will be randomized in a open labeled manner in 1:1 ratio to eupatilin (90mg twice daily-test group, 25 patients) or rebamipide (100mg three times daily-control group paients) for 8 weeks. At week 8, subjects undergo fecal calprotectin test, upper endoscopy and submit symptom diary.
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
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women who were adults at the time of receipt of written consent (age 19-70)
- •Those with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other musculoskeletal diseases that require continuous administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and oral steroids for more than 8 weeks.
- •At screening (before baseline) endoscopy results Modified Lanza Score (MLS) 0~2
- •Those who have not had severe gastrointestinal symptoms in the previous 3 months[Excluding mild abdominal distention, abdominal pain, diarrhea, dyspepsia, nausea, and vomiting]
- •A person who agrees to participate in this clinical trial and voluntarily signs a written consent form
排除标准
- •Those with a history of gastrointestinal surgery (excluding appendectomy)
- •Those who have a history of esophageal cancer, liver cancer, pancreatic cancer, gastric cancer, colon cancer, small intestine tumor or other malignant disease within 5 years from the time of screening
- •Gastrointestinal diseases that are clinically significant by upper gastrointestinal endoscopy, namely active peptic ulcer, reflux esophagitis, gastroesophageal varices, Barrett's esophagus, Barrett's esophagitis, esophageal stenosis, inflammatory bowel disease (Those diagnosed with inflammatory bowel disease, IBD), gastrointestinal bleeding, etc.
- •Those with a history of recurrent gastrointestinal ulcer/perforation
- •Those with cerebrovascular bleeding or confirmed systemic bleeding disorder
- •Persons with severe uncontrolled heart failure (NYHA Class III-IV), high blood pressure (above 160/100 mmHg)
- •Those who have plans for surgical operation during the clinical trial period
- •Persons with a history of chronic pancreatitis, chronic renal diseases, chronic liver diseases, or other serious comorbid diseases
- •Those with clinically significant abnormal values (AST, ALT, BUN, Cr exceeding 2.5 times or Hb<10g/dL) by laboratory examination
- •Those with a history of alcohol or drug abuse/dependence
- •Pregnant and lactating women
- •Those who participated in other clinical trials within 30 days prior to participation in this clinical trial and received investigational drugs or received procedures
- •Patients who are difficult to perform this clinical trial by other investigators or who are judged to have medical findings that are not suitable for the clinical trial
- •Those who received celecoxib and prednisolone (or methylprednisolone) within 30 days prior to participation in this clinical trial
研究组 & 干预措施
rebamipide
take rebamipide to prevent NSAID induced gastroenteropathy
干预措施: Rebamipide (Drug)
eupatilin
take eupatilin to prevent NSAID induced gastroenteropathy
干预措施: Eupatilin (Drug)
结局指标
主要结局
Percentage of patients with gastric damage
时间窗: evaluated at day 56
Percentage of patients with endoscopic Modified Lanza Score \>3
次要结局
- Gastrointestinal symptom(evaluated at day 0 and day 56)
- Fecal calprotectin(evaluated at day 0 and day 56)
- Change of gastric erosion number(evaluated at day 0 and day 56)
- Change of duodenal erosion number(evaluated at day 0 and day 56)
- Change of Modified Lanza Score(evaluated at 0 day and day 56)
- Antioxidant gene expression(evaluated at day 0 and day 56)
研究者
Hyoun Woo Kang
Associate professor
Seoul National University Boramae Hospital