NCT00171483已完成3 期
Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 30
- 试验地点
- 14
- 主要终点
- To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)
研究概览
简要总结
Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heartburn for at least 3 days in the week prior to screening
- •Regurgitation for at least 3 days in the week prior to screening
- •Stable dose PPI therapy > 4 weeks
- •Incomplete relief on daily PPI therapy > 4 weeks
排除标准
- •Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
- •Previous gastrointestinal surgery that may influence esophageal motor function
- •Evidence of cathartic colon or a history of laxative use
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)
次要结局
- To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline)
- To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
- To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients
- To assess patient satisfaction with treatment (end of treatment)
研究者
研究点 (14)
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