NCT02108756Unknown不适用
Efficacy and Safety of L-Pantoprazole Sodium Injection to Treat Upper Gastrointestinal Ulcer Bleeding
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Hemostatic success rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and Efficacy of L- Pantoprazole sodium to treat upper gastrointestinal ulcer bleeding.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years, gender:both.
- •Patients whose Forrest classification were in Ⅰ b-Ⅱ c were diagnosed with non-variceal duodenal and / or gastric ulcer bleeding by endoscopy within 24 hours and patients manifested vomiting and / or black stools and other symptoms of upper gastrointestinal bleeding.
- •Patients were diagnosed with upper gastrointestinal bleeding mild to moderate;
- •Informed consent granted.
- •Patients agreed to take medicine and assess.
排除标准
- •Patients were diagnosed with upper gastrointestinal bleeding by endoscopy caused by esophageal varices and portal hypertensive gastropathy, Mallory-Weiss syndrome, dieulafoy disease.
- •Pregnant women or breastfeeding women.
- •Patients who had undergone surgery because of ulcer complications or gastrectomy, gastrointestinal anastomosis within 30 days before the trial.
- •Patients were diagnosed with gastrinoma or gastric malignancy.
- •Patients had other associated complications, which may affect the efficacy.
- •Patients who like alcohol abuse, drug addicts or others which are not suitable for drug trials.
- •Patients who were allergic to any ingredient of any PPI and allergies.
- •Patients diagnosed with small vessel spurting who had to undergo endoscopic hemostasis or surgery or severe gastrointestinal bleeding.
- •Patients suffering from serious heart, brain, lung, liver, kidney disease or severe hypertension.
- •Patients who had coagulopathy, whose PT wasmore three seconds than normal controls, whose APTT> 1.5 times the upper limit of normal or low-dose heparin treatment.
- •Patients whose systolic blood pressure less than 90mmHg or lower > 30mmHg than the baseline systolic blood pressure, pulse pressure less than 20mmHg, hematocrit less than 20%.
- •Patients who participated in other clinical trials within three months before this trial.
- •Patients who need to use other drugs which may affect the trial during the trial or a week before the trial.
- •Patients who were considered unsuitable for selected candidates.
研究组 & 干预措施
L-pantoprazole sodium
Experimental
干预措施: L-pantoprazole sodium (Drug)
Panmeilu
Active Comparator
干预措施: Panmeilu (Drug)
结局指标
主要结局
Hemostatic success rate
时间窗: 6 days
次要结局
未报告次要终点
研究者
研究点 (1)
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