NCT00471094已完成2 期
A Phase 2 Study to Evaluate the Safety and Efficacy of Ilaprazole (5 mg QD, 20 mg QD and 40 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis.
Takeda0 个研究点目标入组 831 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 831
- 主要终点
- The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of 8 weeks of daily treatment with Ilaprazole (5, 20 and 40 mg), once daily (QD), compared to lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.
详细描述
This 8 week study will be conducted by approximately 160 investigators in the United States. During this study, esophagitis healing will be evaluated by endoscopy, heartburn and other symptom relief will be evaluated by questionnaire and study drug levels will be measured.
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
- •Evidence of uncontrolled, clinically significant systemic disease; acquired immunodeficiency syndrome (AIDs); a condition likely to require surgery; cancer within 5 years of screening; or abnormal laboratory values.
- •Co-existing diseases affecting the esophagus; history of esophageal radiation therapy, cryotherapy, or physiochemical trauma.
- •History of esophageal surgery or dilatation of an esophageal stricture other than Schatzki's ring; gastric or duodenal surgery except simple oversew of an ulcer.
- •Active gastric or duodenal ulcers or acute upper gastrointestinal hemorrhage within 30 days prior to screening.
- •Current or history of Zollinger-Ellison syndrome or other hypersecretory conditions.
- •Allergy to any proton pump inhibitor drug (omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole), any component of Ilaprazole, or antacid.
- •Unable to tolerate lactose.
- •Use of the following medications prior to randomization or anticipated use during the study: proton pump inhibitors, antacids, biphosphonates, histamine (H2) receptor antagonist (examples: Zantac, Tagamet), sucralfate, misoprostol, corticosteroids, prokinetics, Non-steroidal anti-inflammatory drugs (NSAIDs), strong anticholinergics, anticoagulant/anti-platelet aggregate therapy, anticoagulants, digoxin, theophylline, phenytoin.
- •History of alcoholism or drug addiction.
研究组 & 干预措施
Ilaprazole 5 mg QD
Experimental
干预措施: Ilaprazole (Drug)
Ilaprazole 20 mg QD
Experimental
干预措施: Ilaprazole (Drug)
Ilaprazole 40 mg QD
Experimental
干预措施: Ilaprazole (Drug)
Lansoprazole 30 mg QD
Active Comparator
干预措施: Lansoprazole (Drug)
结局指标
主要结局
The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.
时间窗: Week 4
次要结局
- The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.(Week 8)
研究者
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