NCT01069939已完成3 期
A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use
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
- 427
- 试验地点
- 1
- 主要终点
- Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.
研究概览
简要总结
To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent before starting the study-related procedures and examinations
- •Patients who have the history of gastric and/or duodenal ulcer.
- •A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period.
排除标准
- •Having gastric or duodenal ulcer (except for ulcer scar).
- •History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.
研究组 & 干预措施
Esomeprazole 20mg
Experimental
Esomeprazole 20mg once daily oral
干预措施: Esomeprazole (Drug)
Placebo
Placebo Comparator
Placebo once daily oral
干预措施: Placebo (Drug)
结局指标
主要结局
Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.
时间窗: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)
Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks.
次要结局
- Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48(Up to 48 weeks (Baseline to last measurement))
- Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.(12, 24, 36 and 48 weeks)
- Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48(Up to 48 weeks (Baseline to last measurement))
- Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.(Up to 48 weeks (Baseline to last measurement))
- Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48(Up to 48 weeks (Baseline to last measurement))
- Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week(Up to 48 weeks (Baseline to last measurement))
- Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48(Up to 48 weeks (Baseline to last measurement))
- Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48(Up to 48 weeks (Baseline to last measurement))
- Number of Participants With Adverse Events(Up to 70 weeks at the longest)
研究者
研究点 (1)
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