NCT00608712已完成4 期
Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 140
- 主要终点
- To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss
研究概览
简要总结
Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery for body weight reduction
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed and dated
- •BMI ≥40 kg/m2 or BMI between 35 and 40 kg/m2, but with a severe disease together with obesity
- •Indication for gastric bypass surgery
- •Upper digestive endoscopy prior to surgery not showing esophagitis, erosions, ulcers or neoplasia, examination performed up to 30 days before surgery being considered valid
- •Helicobacter pylori non-infected patients, diagnosed by tests carried out up to 30 days before surgery
排除标准
- •Contraindication for gastric bypass surgery
- •Contraindication to use Omeprazole and derivatives
- •Patients carriers of gastrinoma or having hypergastrinemia
- •Patients contraindicated to perform UDE
- •Patients with previous esophagogastroduodenal surgery
结局指标
主要结局
To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss
次要结局
- To evaluate the efficacy of Esomeprazole in avoiding appearance of related peptic acid symptoms after gastric bypass surgery for weight loss.
研究者
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