NCT01474369已完成3 期
A Phase 3, Randomized, Double Blind, Placebo Control, Multicenter Study to Evaluate the Efficacy and Safety of TAK- 438 (10 and 20 mg Once-Daily) in Patients With Non-Erosive Gastroesophageal Reflux Disease.
Takeda0 个研究点目标入组 827 人开始时间: 2011年12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
- 827
- 主要终点
- Percentage of symptom-free days of heartburn symptoms
研究概览
简要总结
The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.
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 with grade N or M in the modified LA classification system confirmed by endoscopy at initiation of the pre-observation period (VISIT 1).
- •Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2 days or more in one week in the 3 weeks before initiation of initiation of the pre-observation period (VISIT 1).
- •Participants with severity* of moderate or higher for acid reflux symptoms (heartburn or regurgitation) in the 3 weeks before initiation of the pre-observation period (VISIT 1)
- •* Severity: No symptoms, very mild (symptoms present but often forgotten), mild (not so painful), moderate (rather painful), severe (painful) and very severe (painful enough to affect night time sleep or daily activities)
- •Outpatients (hospitalization for testing possible)
排除标准
- •Participants with an esophagus-related complication [Barrett's esophagus (3 cm or more, LSBE), eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infections, esophageal stenosis, etc.], or a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Barrett's esophagus (less than 3 cm, SSBE) or Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) 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 ulcers (mucosal defects associated with white coating) or duodenal ulcers (mucosal defect with white coating) within 30 days before initiation of the pre-observation period (VISIT 1) However, participants with gastric or duodenal erosions are allowed to be included.
- •Participants with acute gastritis or acute exacerbation of chronic gastritis as a complication
- •Participants with a previous or current history of the Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders
- •Participants with a history of chest pain due to heart disease or with chest pains suspected of being caused by heart disease within one year before initiation of the pre-observation period (VISIT 1)
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)
Placebo QD
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of symptom-free days of heartburn symptoms
时间窗: Week 4
Heartburn symptoms will be collected by participant diaries.
Cumulative symptom improvement rate of heartburn symptoms
时间窗: Week 4
Heartburn symptoms will be collected by participant diaries.
Severity of heartburn symptoms
时间窗: Week 4
Heartburn symptoms will be collected by participant diaries.
次要结局
- Heartburn symptoms stratified by response (improvement or non-improvement) at Week 2(Week 4)
- Heartburn Symptoms Stratified by Baseline Endoscopic Findings (Grade N or M)(Week 4)
- Heartburn symptoms stratified by combination of response at Week 2 and baseline endoscopic findings (improvement and grade N, improvement and grade M, non-improvement and grade N, non-improvement and grade M.)(Week 4)
研究者
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