NCT00390975终止4 期
An Open-label Pilot Trial to Assess the Effect of Tegaserod on Improvement of Gastric Emptying in Patients With Diabetic Gastroparesis and Upper Gastrointestinal Symptoms
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Proportion of patients treated with tegaserod that improve gastric emptying at Week 2 as compared with baseline via a solid phase technetium gastric emptying time (GET)
研究概览
简要总结
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females and males 18 to 75 years of age
- •History of type I or type II diabetes mellitus for more than 3 years
- •History of upper gastrointestinal symptoms consistent with diabetic gastroparesis
- •Hemoglobin A1c < 9.5%
- •Delayed gastric emptying
排除标准
- •Abnormal endoscopy finding that can explain the presence of gastroparesis symptoms
- •Medical conditions affecting gastric emptying
- •A clinically significant medical condition that would interfere with the patient completing the trial
- •Clinically significant abnormal creatinine level
- •Known allergies to the same class of drug and/or allergies to eggs
- •Severe obesity
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Proportion of patients treated with tegaserod that improve gastric emptying at Week 2 as compared with baseline via a solid phase technetium gastric emptying time (GET)
次要结局
- Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptying
- Symptoms of diabetic gastroparesis including postprandial fullness, early satiety, bloating, nausea and vomiting, and abdominal discomfort
- Volume and symptomatic response to a gastric satiety drink test (GSDT)
- Electrogastrography (EGG)
- The safety and tolerability of tegaserod
研究者
研究点 (6)
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