NCT00336219已完成3 期
COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes
Takeda1 个研究点 分布在 1 个国家目标入组 628 人开始时间: 2006年8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
- 628
- 试验地点
- 1
- 主要终点
- symptom assessment as measured by ReQuest™ questionnaire and investigator.
研究概览
简要总结
The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Written informed consent
- •Outpatients
- •History of GERD-related symptoms for at least 6 months prior to study inclusion
- •Endoscopically confirmed erosive GERD or non-erosive GERD
排除标准
- •Acute peptic ulcer and/or ulcer complications
- •PPIs during last 7 days prior to study start
- •Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day
- •Intake of PPIs in combination with antibiotics for eradication of H. pylori
研究组 & 干预措施
1
Active Comparator
Pantoprazole 40 mg
干预措施: Pantoprazole (Drug)
结局指标
主要结局
symptom assessment as measured by ReQuest™ questionnaire and investigator.
时间窗: 28 days
次要结局
- symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator(28 days)
- endoscopic healing after 28 days(28 days)
- health-related quality of life after 28 days(28 days)
- safety.(28 days)
研究者
研究点 (1)
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