NCT00762359终止3 期
A Study to Investigate the Preventive Effect of AG-1749 Against the Recurrence of Gastric And Duodenal Ulcers During Long-Term Treatment With Low Dose Aspirin.
Takeda0 个研究点目标入组 461 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 461
- 主要终点
- Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
研究概览
简要总结
The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.
详细描述
In Japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary artery by-pass surgery and percutaneous transluminal coronary angioplasty in patients. While low-dose aspirin is effective in these cases, its use sometimes causes gastric and duodenal ulcers which can lead to gastrointestinal bleeding, and in worse cases may lead to death.
The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily low dose aspirin therapy.
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
- 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
- •The patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
- •The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.
排除标准
- •Endoscopically confirmed gastric and/or duodenal ulcers on Day
- •Endoscopically confirmed active upper gastrointestinal hemorrhage on Day
- •Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs.
- •Past or planned surgery affecting gastric acid secretion.
- •Clinically significant hepatic or renal disorder.
研究组 & 干预措施
Lansoprazole 15 mg QD
Experimental
干预措施: Lansoprazole (Drug)
Gefarnate 50 mg BID
Active Comparator
干预措施: Gefarnate (Drug)
结局指标
主要结局
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
时间窗: 18 Months
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
次要结局
- Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)(Baseline and Month 3.)
- Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)(Baseline and Month 6.)
- Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)(Baseline and Month 9.)
- Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)(Baseline and Month 12.)
- Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)(Baseline and Month 18.)
- Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)(Baseline and Month 3.)
- Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)(Baseline and Month 6.)
- Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)(Baseline and Month 12.)
- Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)(Baseline and Month 9.)
- Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)(Baseline and Month 12.)
- Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)(Baseline and Month 18.)
- Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)(18 Months)
- Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)(Baseline and Month 3.)
- Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)(Baseline and Month 6.)
- Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)(Baseline and Month 9.)
- Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)(Baseline and Month 12.)
- Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)(Baseline and Month 18.)
- Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)(Baseline and Month 3.)
- Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)(Baseline and Month 6.)
- Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)(Baseline and Month 9.)
- Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)(Baseline and Month 12.)
- Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)(Baseline and Month 18.)
- Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)(Baseline and Month 3.)
- Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)(Baseline and Month 6.)
- Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)(Baseline and Month 9.)
- Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)(Baseline and Month 18.)
- Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)(Baseline and Month 3.)
- Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)(Baseline and Month 6.)
- Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)(Baseline and Month 9.)
- Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)(Baseline and Month 12.)
- Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)(Baseline and Month 18.)
- Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)(Baseline and Month 3.)
- Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)(Baseline and Month 6.)
- Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)(Baseline and Month 9.)
- Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)(Baseline and Month 12.)
- Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)(Baseline and Month 18.)
- Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)(Baseline and Month 3.)
- Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)(Baseline and Month 6.)
- Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)(Baseline and Month 9.)
- Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)(Baseline and Month 12.)
- Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)(Baseline and Month 18.)
- Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)(Baseline and Month 3.)
- Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)(Baseline and Month 6.)
- Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)(Baseline and Month 9.)
- Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)(Baseline and Month 12.)
- Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)(Baseline and Month 18.)
- Number of Participants With Adverse Events(18 Months)
研究者
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