NCT01456260已完成3 期
A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
Takeda0 个研究点目标入组 406 人开始时间: 2011年9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
- 406
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.
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
- Single (Participant)
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
- •Participants who require continuous NSAID therapy during the treatment period with the study drug
- •Participants who have completed the preceding study
- •Outpatient (including inpatient for examinations)
排除标准
- •Participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study
- •Participants who are scheduled to change the type and dosage regimen of NSAID
- •Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study
- •Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
- •Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
- •Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- •Participants with a previous or current history of aspirin-induced asthma
研究组 & 干预措施
TAK-438 10 mg QD
Experimental
干预措施: TAK-438 (Drug)
TAK-438 10 mg QD
Experimental
干预措施: Placebo (Drug)
TAK-438 20 mg QD
Experimental
干预措施: TAK-438 (Drug)
TAK-438 20 mg QD
Experimental
干预措施: Placebo (Drug)
Lansoprazole 15 mg QD
Active Comparator
干预措施: Lansoprazole (Drug)
Lansoprazole 15 mg QD
Active Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: Up to 80 weeks.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit of study.
次要结局
- Change from baseline in Laboratory values(Up to 80 weeks.)
- Change from baseline in Electrocardiograms(Up to 80 weeks.)
- Change from baseline in Vital signs(Up to 80 weeks.)
- Change from baseline in Serum gastrin(Up to 80 weeks.)
- Change from baseline in Pepsinogen I and II(Up to 80 weeks.)
- Recurrence rate of gastric or duodenal ulcer(Up to 80 weeks.)
研究者
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