A Randomized Comparison of High Dose Oral to Intravenous Esomeprazole in Patients After Endoscopic Control to Their Bleeding Peptic Ulcers: an Intra-gastric pH Study.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The primary measure of this study is the median gastric pH over 24-hour monitoring.
研究概览
简要总结
The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by 8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in such a high dose either intravenous or orally is identical.
详细描述
Bleeding peptic ulcer is a common and life threatening condition. Endoscopic therapy has become the mainstay of controlling bleeding. Recurrent bleeding after endoscopic control occurs in about 20% of patients with a high associated mortality. We previously demonstrated that the adjunct use of high dose proton pump inhibitor reduces risk of recurrent bleeding and thereby improves patients' outcome [Lau JY N Engl J Med 2000]. The newer PPI, esomeprazole, is an S-isomer of omeprazole. Esomeprazole is more effective in gastric acid control as measured by both basal and pentagastrin acid output when compared to omeprazole. Esomeprazole when given orally at a lower dose achieves a similar gastric control than intravenous esomeprazole. The gastric pH with a high dose esomeprazole when given either orally or intravenously has not been measured among Hong Kong Chinese. If a high dose oral esomeprazole achieves a similar pH control near gastric neutrality, the oral regime can be used in place of the intravenous formulation. This represents significant convenience in dosing and cost savings.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted with diagnosis of upper gastrointestinal bleeding aged between 18 and 80
- •Endoscopic confirmation of a bleeding duodenal or gastric ulcer to which endoscopic control has been obtained
- •Absence of H. pylori infection
- •Informed written consent
排除标准
- •Known incompatibility to the study drugs;
- •Known incompatibility and hypersensitivity to proton pump inhibitor
- •H. pylori infection
- •Recent H2RA or PPI use (within last 4 weeks)
- •Concomitant use of medications that may interfere gastric acid secretion or motility (e.g. anticholinergic, metoclopramide, domperidone)
- •Pregnancy or lactation;
- •Non-compliance e.g. mental subordination
- •Nasopharyngeal or oropharyngeal pathology that would prevent passage of a nasal catheter
- •Significant liver disease as PPI is metabolized by the cytochrome P-450 system
- •Previous gastric surgery
- •Chronic Aspirin user
- •Presence of esophageal/ gastric varices
- •Moribund patients, terminal malignancy & patients with severe renal disease
- •Patient unable to give written consent
研究组 & 干预措施
Oral Nexium
Oral esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 40mg every 12 hours for 24 hours
干预措施: Oral esomeprazole (Drug)
IV Nexium
Intravenous bolus injection of esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
干预措施: Intravenous bolus injection of esomeprazole (Drug)
结局指标
主要结局
The primary measure of this study is the median gastric pH over 24-hour monitoring.
时间窗: 24 hours
次要结局
- acid suppressing activity, notably the rate of onset of action, between the two treatment regimens: 1. Percentage time of pH<6 2. Time to reach pH 6 3. Median gastric pH in the first 6 and 12 hours(24 hours)
研究者
James Yun-wong Lau
Professor
Chinese University of Hong Kong