NCT00325676已完成4 期
CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD
Takeda46 个研究点 分布在 4 个国家目标入组 639 人开始时间: 2006年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 639
- 试验地点
- 46
- 主要终点
- time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
研究概览
简要总结
The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.
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
- None
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
- •Main Inclusion Criteria:
- •Written informed consent
- •Endoscopically confirmed GERD (Los Angeles classification A-D)
- •Patients whose compliance is expected to be high with respect to the completion of the questionnaires
排除标准
- •Other gastrointestinal diseases
- •Severe concomitant diseases
- •Proton pump inhibitors (PPIs) during last 14 days before start
- •H2 receptor antagonists, prokinetics during last 7 days before study start
- •Helicobacter pylori (H. pylori) eradication during last 28 days before study start
结局指标
主要结局
time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
次要结局
- further efficacy criteria
- safety
研究者
研究点 (46)
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