A Multicenter, Open-label, Four-way Crossover Study of the Effects of Esomeprazole, Aspirin and Rofecoxib on Prostaglandin (PGE2) Production, Cyclooxygenase-2 Enzyme Activity and PCNA Expression in Patients With Barrett's Esophagus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 32
- 主要终点
- Measure PGE production in Barrett's metastatic tissue & determine the reduction from baseline of PGE production would be equivalent on Day 10 in esomeprazole 40mg bid + aspirin treatment compared to esomeprazole 40 mg bid + rofecoxib 25 mg qd treatment
研究概览
简要总结
This study evaluates PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue. All patients will have a baseline endoscopy with multiple biopsies. The patients will then be receive four dosing regimens (esomeprazole, esomeprazole and aspirin, esomeprazole and rofecoxib, or rofecoxib alone) consecutively each for a 10 day dosing period, whilst undergoing further follow up endoscopies and multiple biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •A biopsy-proven diagnosis of Barrett's esophagus segment length greater than 2cm with no dysplasia or adenocarcinoma.
- •Clinically normal laboratory results and physical findings at screening.
排除标准
- •A history of esophageal, gastric or duodenal surgery, including antireflux surgery or endoscopic antireflux procedures, except for simple closure of an ulcer.
- •Evidence of the following diseases or conditions:
- •Barrett's esophagus less than or greater than 2cm that is positive for high grade dysplasia or adenocarcinoma
- •Signs and symptoms of gastric outlet obstruction
- •Active peptic ulcer disease
- •severe liver disease
- •Pancreatitis
- •Malabsorption
- •Active inflammatory bowel disease
- •Severe pulmonary, cardiovascular or renal disease
- •Impaired renal function or abnormal urine sediment on repeated examinations
- •esophageal stricture or active, severe esophagitis.
研究组 & 干预措施
1
Nexium 40mg
干预措施: Esomeprazole (Drug)
2
Nexium 40mg + aspirin
干预措施: Esomeprazole (Drug)
2
Nexium 40mg + aspirin
干预措施: Aspirin (Drug)
3
Nexium 40mg + Rofecoxib 25 mg
干预措施: Esomeprazole (Drug)
4
Rofecoxib 25mg
干预措施: Rofecoxib (Drug)
结局指标
主要结局
Measure PGE production in Barrett's metastatic tissue & determine the reduction from baseline of PGE production would be equivalent on Day 10 in esomeprazole 40mg bid + aspirin treatment compared to esomeprazole 40 mg bid + rofecoxib 25 mg qd treatment
时间窗: Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period.
次要结局
- To determine in which of the four treatment groups the reduction in the baseline in PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue is the greatest.(Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period)