NCT00787254已完成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 Nonsteroid Anti-inflammatory Drug
Takeda0 个研究点目标入组 366 人开始时间: 2007年4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
- 已完成
- 发起方
- 入组人数
- 366
- 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 AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).
详细描述
In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of 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 nonsteroid anti-inflammatory medication.
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 nonsteroid anti-inflammatory drug (NSAID) 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 NSAIDs.
- •Past or planned surgery affecting gastric acid secretion.
- •Clinically significant hepatic or renal disorder.
- •Serious cardiac dysfunction, hypertension, or hematological 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: 24 Months
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 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 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 Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)(Baseline and Month 6.)
- Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)(Baseline and Month 24.)
- 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 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.)
- Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)(Baseline and Month 24.)
- Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)(On occurrence (up to month 24).)
- 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 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 Postprandial Pain Gastrointestinal Symptom (Month 24)(Baseline and Month 24.)
- 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 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 Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)(Baseline and Month 24.)
- 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 12)(Baseline and Month 12.)
- 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 Enlarged Abdomen Gastrointestinal Symptom (Month 24)(Baseline and Month 24.)
- 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 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 Nausea Gastrointestinal Symptom (Month 24)(Baseline and Month 24.)
- 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 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 Feeling of Heartburn Gastrointestinal Symptom (Month 24)(Baseline and Month 24.)
- 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 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 Anorexia Gastrointestinal Symptom (Month 24)(Baseline and Month 24.)
- 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 12)(Baseline and Month 12.)
- Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)(Baseline and Month 18.)
- Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)(Baseline and Month 24.)
- Number of Participants With Adverse Events(Per Incidence (up to 24 months).)
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