NCT01452776已完成3 期
A Phase 3, Randomized, Single-Blind, Multicenter Study to Evaluate the Safety of TAK-438 (10 and 20 mg Once-daily) in a 52-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE)
Takeda0 个研究点目标入组 305 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
- 305
- 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 determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.
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
- 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 must have successfully completed the preceding phase 3 double-blind study (TAK-438/CCT-002: preceding study) and have endoscopically healed EE at Week 2, 4, or 8 in the preceding study.*
- •* "Endoscopically healed EE" is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System.
- •Outpatient (including inpatient for examination)
排除标准
- •Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
- •Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
- •Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit M-1 (initiation of study drug administration). However, participants with gastric or duodenal erosions are allowed to be included.
- •Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorder
研究组 & 干预措施
TAK-438 10 mg QD
Experimental
干预措施: TAK-438 (Drug)
TAK-438 20 mg QD
Experimental
干预措施: TAK-438 (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events
时间窗: 52 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.
次要结局
- Change from Baseline in Laboratory Values(Baseline and Week 52)
- Change from Baseline in Electrocardiograms(Baseline and Week 52)
- Change from Baseline in Vital Signs(Baseline and Week 52)
- Change from Baseline in Serum Gastrin(Baseline and Week 52)
- Change from Baseline in Pepsinogen I and II(Baseline and Week 52)
- Endoscopically confirmed recurrence rate of Erosive Esophagitis(52 Weeks)
研究者
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