NCT00171457已完成3 期
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
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
- 24
- 试验地点
- 2
- 主要终点
- To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach
研究概览
简要总结
Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Male or female subjects at least 18 years of age.
- •Subjects willing to undergo multiple nasogastric intubations.
- •Patients with functional heartburn will need to meet ROME II criteria.
- •Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety)
排除标准
- •Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS.
- •Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease.
- •Subjects with Diffuse Esophageal Spasm or Achalasia.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach
次要结局
- 1) Comparing effects at end of treatment compared to baseline:
- To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort
- To determine if tegaserod improves heartburn and/or regurgitation
- To verify that tegaserod modulates esophageal sensitivity to esophageal distention
- To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo
- Safety assessment
- To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi
研究者
研究点 (2)
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