NCT01452724已完成3 期
A Phase 3, Randomized, Double Blind, Double-Dummy, Multicenter, Parallel Group Comparison Study to on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Comparing With AG-1749 in Patients With Duodenal Ulcer
Takeda0 个研究点目标入组 372 人开始时间: 2011年10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
- 372
- 主要终点
- Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks
研究概览
简要总结
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
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
- •Participants must have endoscopically confirmed duodenal ulcers (mucosal defect with white coating) .At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1).
- •Outpatient (including short inpatient for examination and others)
排除标准
- •Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
- •Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
- •Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
- •Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
- •Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
- •Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
- •Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
- •Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- •Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)
研究组 & 干预措施
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 30 mg QD
Active Comparator
干预措施: Lansoprazole (Drug)
Lansoprazole 30 mg QD
Active Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks
时间窗: 6 weeks
Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.
次要结局
- Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks(4 weeks)
- Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2(2 weeks)
- Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer(Baseline and 6 weeks)
研究者
相似试验
已完成
3 期
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric UlcerGastric UlcerNCT01452711Takeda482
已完成
3 期
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive EsophagitisErosive EsophagitisNCT01452698Takeda409
已完成
3 期
Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux DiseaseNon-erosive Gastroesophageal Reflux DiseaseNCT01474369Takeda827
已完成
3 期
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive EsophagitisErosive EsophagitisNCT01459367Takeda607
已完成
3 期
Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose AspirinGastric UlcersDuodenal UlcersNCT01452763Takeda621