Efficacy of DA-5204 on Gastroesophageal Reflux Disease
关键词
抽象
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).
日期
| 最后验证: | 05/31/2019 |
| 首次提交: | 06/24/2019 |
| 提交的预估入学人数: | 06/24/2019 |
| 首次发布: | 06/25/2019 |
| 上次提交的更新: | 06/24/2019 |
| 最近更新发布: | 06/25/2019 |
| 实际学习开始日期: | 05/31/2016 |
| 预计主要完成日期: | 12/10/2018 |
| 预计完成日期: | 12/10/2018 |
状况或疾病
干预/治疗
Drug: Pantoprazole
Drug: Pantoprazole and DA-5204
Drug: Pantoprazole and placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Pantoprazole and DA-5204 Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks | Drug: Pantoprazole and DA-5204 DA-5204 tablet |
| Active Comparator: Pantoprazole and placebo Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks | Drug: Pantoprazole and placebo Film-coated tablet manufactured to mimic DA-5204 |
资格标准
| 有资格学习的年龄 | 20 Years 至 20 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. Endoscopically effective improvement [4 weeks]
2. Endoscopically complete improvement [4 weeks]
次要成果指标
1. Symptom improvement [4 weeks]
