NCT00557349已完成4 期
A Randomized, Double-blind Clinical Trial Comparing Zegerid Capsule to Famotidine in Preventing Anastomotic (Marginal) Ulcers in Post Gastric Bypass Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.
研究概览
简要总结
This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.
详细描述
The purpose of this research is to evaluate information about the control of gastric acid in post gastric bypass surgery patients. Goal is to determine which medication best reduces the incidence of anastomotic ulcers post-operatively.
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
- Double (Investigator, Outcomes Assessor)
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
- •Subject is age ≥ 18 years
- •Patient meets the criteria for laparoscopic gastric bypass surgery
- •Females only: Patient is willing to take a urine pregnancy test
排除标准
- •Subject allergic to omeprazole or famotidine
- •Patient receiving antifungal (i.e. ketoconazole or itraconazole)
- •Hepatic insufficiency
- •History of Crohns disease
- •History of Zollinger-Ellison disease
- •Patient received an investigational drug within 30 days of enrollment
- •Patient currently enrolled in another research project
- •Females Only: Pregnancy or plan on becoming pregnant during the next 14 weeks
研究组 & 干预措施
Omeprazole
Active Comparator
40 mg Omeprazole daily
干预措施: Omeprazole (Drug)
Famotidine
Active Comparator
40 mg Famotidine daily
干预措施: Famotidine (Drug)
结局指标
主要结局
Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.
时间窗: during first 14 weeks after surgery
次要结局
- Number of Participants With Upper Endoscopy Indicated Due to Complaints(during first 14 weeks after surgery)
研究者
研究点 (1)
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