Efficacy of DA-5204 (Stillen 2X®) for Patients With Gastroesophageal Reflux Disease: A Randomized, Double-blind, Placebo-controlled Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Endoscopically effective improvement
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled clinical Study to evaluate the efficacy of DA-5204 and proton pump inhibitor combination therapy compared with proton pump inhibitor alone therapy in patients with gastroesophageal reflux Disease.
详细描述
Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the esophagus causes troublesome symptoms, such as heartburn and acid regurgitation.
Proton pump inhibitors, as acid suppressor, are the agents recommended as the first-line treatment for gastroesophageal reflux disease. However, approximately 20-30% of patients have insufficient effect on this therapy alone.
DA-5204 is a medicine based on Artemisia asiatica 95% ethanol extract. DA-5204 has been administered to treat gastritis and gastric ulcers with antioxidative and cytoprotective actions on gastric mucosal damage. Therefore, we expect DA-5204 to be effective in reflux esophagitis (esophageal mucosal injury).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is over 20 years old, under 75 years old, men or women
- •Patients diagnosed with erosive esophagitis by gastroscopy
- •Signed the informed consent forms
排除标准
- •Patients who is impossible to receive gastroscopy
- •Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic ulcer or gastrointestinal bleeding
- •Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 4 weeks
- •Patients with surgery related to gastroesophageal
- •Patients with Zollinger-Ellison syndrome
- •Patients with any kind of malignant tumor
- •Patients administered with anti-thrombotic drugs
- •Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
- •Patients with neuropsychiatric disorder, alcoholism, or drug abuse
- •Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.
- •Women either pregnant or breast feeding
研究组 & 干预措施
Pantoprazole and DA-5204
Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks
干预措施: Pantoprazole (Drug)
Pantoprazole and DA-5204
Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks
干预措施: DA-5204 (Drug)
Pantoprazole and placebo
Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks
干预措施: Pantoprazole (Drug)
Pantoprazole and placebo
Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Endoscopically effective improvement
时间窗: 4 weeks
A percentage of subjects showed effective improvement of erosive esophagitis (esophageal mucosal injury) by the endoscopy. The definition of "effective improvement" is the subjects showed score changed from 3 to 0, from 2 to 0, or from 3 to 1. \[score 0(LA grade N): normal mucosa, score 1(LA grade M): minimal changes to the mucosa such as erythema, blurring and/or whitish turbidity, score 2(LA grade A): non-confluent mucosal breaks \<5 mm in length, score 3(LA grade B): non-confluent mucosal breaks ≥5 mm in length\]
Endoscopically complete improvement
时间窗: 4 weeks
A percentage of subjects showed complete improvement of erosive esophagitis (esophageal mucosal injury) by the endoscopy. The definition of "complete improvement" is the subjects showed score changed from 3 to 0 or from 2 to 0.
次要结局
- Symptom improvement(4 weeks)
研究者
Dong Ho Lee
Director, Clinical Research
Seoul National University Hospital