NCT00171418已完成3 期
Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) 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
- 54
- 试验地点
- 4
- 主要终点
- To determine the effect of 4 weeks of tegaserod treatment in addition to PPI on clinically meaningful incremental gain in improvement of overall GERD symptoms, based on weekly binary questions.
研究概览
简要总结
Study to assess the effects of adding tegaserod to PPI therapy results in clinically meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on daily PPI therapy alone.
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
- •GERD symptoms for at least 6 months
- •PPI therapy for at least 4 weeks
- •Incomplete symptom relief on daily PPI therapy
- •No erosive disease as evidenced in EGD/no change in symptom severity
排除标准
- •Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
- •Previous gastrointestinal surgery that may influence esophageal motor function
- •Known primary esophageal motor disorder other than Inefficient Esophageal Motor Disorder
- •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 4 weeks of tegaserod treatment in addition to PPI on clinically meaningful incremental gain in improvement of overall GERD symptoms, based on weekly binary questions.
次要结局
- To evaluate the sensitivity of three global symptom assessments, including two binary scales and a Likert-type scale along with a composite symptom index (end of treatment compared to baseline)
- To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
- Safety assessment
研究者
研究点 (4)
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