NCT00312806已完成3 期
Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks
Takeda187 个研究点 分布在 6 个国家目标入组 2,000 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 187
- 主要终点
- Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
研究概览
简要总结
The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. 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
- •Main Inclusion Criteria:
- •Written informed consent
- •Outpatients of at least 18 years (21 years in Argentina)
- •Patient considered to have GERD symptoms
排除标准
- •Acute peptic ulcer and/or ulcer complications
- •Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day)
- •Intake of proton pump inhibitors during the last 10 days before study start
- •Female patients of childbearing potential not using adequate means of birth control
- •Pregnant or breast-feeding females
结局指标
主要结局
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
时间窗: 8 weeks
次要结局
- Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™(4 and 8 weeks)
- Investigator assessment(4 and 8 weeks)
- Safety and efficacy(4 and 8 weeks)
研究者
研究点 (187)
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