NCT00050609已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of IC351 (LY450190) in Patients With Diabetic Gastroparesis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 5 mg tadalafil compared to placebo
研究概览
简要总结
The purposes of this study are to determine whether an experimental drug known as tadalafil can reduce symptoms of dyspepsia (fullness after eating, inability to finish a regular meal, bloating, discomfort or pain in the upper abdomen, belching after meals, nausea, vomiting) in diabetic patients, and/or reduce the amount of time the stomach takes to empty the contents of a standard meal. The safety of tadalafil given once daily for 8 weeks in this population will also be studied.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus
- •Delayed gastric emptying
- •3 month minimum history of chronic upper abdominal discomfort
- •Symptoms of dyspepsia (upset stomach)
排除标准
- •Major gastrointestinal surgery or medical conditions known to affect gastric motility
- •Irritable Bowl Syndrome
- •Medications known to affect gastric motility
- •Angina treated with nitrates
- •Uncontrolled diabetes mellitus and history of certain heart problems
研究组 & 干预措施
1
Placebo Comparator
干预措施: placebo (Drug)
2
Active Comparator
5 mg tadalafil
干预措施: tadalafil (Drug)
3
Active Comparator
20 mg tadalafil
干预措施: tadalafil (Drug)
结局指标
主要结局
Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 5 mg tadalafil compared to placebo
时间窗: 8 weeks
次要结局
- Measure of change from baseline to endpoint using the Visual Analog Score and Nepean Dyspepsia Index Symptom Checklist in patients taking 5 mg tadalafil, 20 mg tadalafil and placebo(8 weeks)
- Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 20 mg tadalafil compared to placebo(8 weeks)
研究者
研究点 (1)
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