NCT00142974终止2 期
Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.
研究概览
简要总结
This study is being done to evaluate the safety, tolerability and satisfactory relief of tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic gastropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of Type 1 or insulin-requiring Type 2 diabetes for at least 3 years
- •GI symptoms for at least 2 months before entering study
排除标准
- •Very high body weight
- •Significant diarrhea
- •Symptom severity score collected via diary Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.
次要结局
- Weekly global measure of dyspeptic symptom relief.
- Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety).
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.DyspepsiaNCT00171470Novartis60
已完成
3 期
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With DyspepsiaDyspepsiaNCT00232024Novartis1,296
已完成
3 期
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With DyspepsiaDyspepsiaNCT00232089Novartis1,296
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).Gastroesophageal Reflux Disease (GERD)NCT00171418Novartis54
已完成
3 期
Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.Chronic ConstipationNCT00141089Novartis1,026