NCT00441727已完成3 期
A Randomized, Double-blind, Parallel-group, Multicentre, Phase III Study to Assess the Effect of Esomeprazole 20 or 40 mg od Versus Placebo on the Occurrence of Peptic Ulcers During 26 Weeks in Subjects on Continuous Low Dose Acetylsalicylic Acid (ASA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,426
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
研究概览
简要总结
The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.
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
- Quadruple (Participant, Care Provider, 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
- •Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the following (a-e):
- •Aged ≥65 years.
- •Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).
- •Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization).
- •Aged ≥60 years and with stable coronary artery disease.
- •Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.
排除标准
- •Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).
- •Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
- •History of peptic ulcer complications such as clinically significant bleeding and/or perforation.
研究组 & 干预措施
Esomeprazole 40 mg
Experimental
Esomeprazole 40 mg
干预措施: Esomeprazole 40 mg (Drug)
Esomeprazole 20 mg
Experimental
Esomeprazole 20 mg
干预措施: Esomeprazole 20 mg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
时间窗: During 26 weeks
The occurrence of ulcer (mucosal break measuring \>= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
次要结局
- Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.(During 26 weeks)
- Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.(During 26 weeks)
- Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.(RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.)
- Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.(RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.)
- Number of Participants With Gastric and/or Duodenal Erosions.(The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.)
研究者
研究点 (1)
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