A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once- Daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,038
- 主要终点
- Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.
详细描述
This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last 8 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D)
排除标准
- •Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
- •Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
- •Use of antacids [except for study supplied Gelusil®]
- •Need for continuous anticoagulant therapy (blood thinners)
- •Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
- •History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
- •Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
- •History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
- •Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy
研究组 & 干预措施
Dexlansoprazole MR 60 mg QD
干预措施: Dexlansoprazole MR (Drug)
Dexlansoprazole MR 90 mg QD
干预措施: Dexlansoprazole MR (Drug)
Lansoprazole 30 mg QD
干预措施: Lansoprazole (Drug)
结局指标
主要结局
Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
时间窗: 8 Weeks
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
时间窗: 8 weeks
Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
次要结局
- Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.(8 Weeks)
- Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.(8 Weeks)
- Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.(4 Weeks)
- Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.(4 Weeks)