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临床试验/NCT01093755
NCT01093755已完成4 期

Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?: A Randomized Controlled Trial

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年3月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
Mayo Clinic
入组人数
30
试验地点
1
主要终点
Change in Inflammation Biomarker Tissue PGE2 Level

研究概览

简要总结

The investigators hypothesize that intensive acid suppression with a long acting high potency proton pump inhibitor (PPI) drug dexlansoprazole will lead to a greater decrease in levels of inflammatory mediators (compared to conventional PPIs) in the esophagus, which could potentially lead to decreased recurrence of intestinal metaplasia following endoscopic ablation.

详细描述

Patients who achieve complete remission of intestinal metaplasia following ablation will be randomized (using concealed allocation, like the flip of a coin) to either intensive acid suppression with dexlansoprazole 60-90 mg/day or to symptom guided acid suppression with escalating doses of omeprazole (20-60 mg/day) for 6 months. Control of reflux will be assessed using 24 hour ambulatory pH monitoring. The need to escalate drug dosage at the 3 month visit will be determined by presence of excessive acid exposure on ambulatory pH monitoring. Biopsies of esophageal tissue will be obtained at baseline, then at 3 months and 6 months following randomization to measure changes in inflammatory biomarkers.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

dexlansoprazole

Active Comparator

Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months

干预措施: dexlansoprazole (Drug)

omeprazole

Active Comparator

Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.

干预措施: Omeprazole (Drug)

结局指标

主要结局

Change in Inflammation Biomarker Tissue PGE2 Level

时间窗: 3 months, 6 months

Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay

Change in Esophageal Inflammation Biomarker COX-2 Gene Expression

时间窗: 3 months, 6 months

Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prasad G. Iyer

MD

Mayo Clinic

研究点 (1)

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