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
- 2,054
- 主要终点
- Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
研究概览
简要总结
This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) 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 and 90 mg) 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 up to 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 (UGI) 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 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. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. 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. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. 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 - Life Table Method.(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 - Crude Rate Analysis.(Week 8)
- Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method(4 Weeks)
- Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.(4 Weeks)