NCT01161602已完成2 期
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Multiple Dose Levels of Pumosetrag in Patients With Symptoms Associated With Gastroesophageal Reflux Disease (GERD) Receiving a Standard Refluxogenic Meal
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 5
研究概览
简要总结
The purpose of this study is to determine if pumosetrag is effective in treating Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD symptoms and are currently taking an acid suppression therapy, such as a Proton Pump Inhibitor (PPI).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with history of Gastroesophageal Reflux Disease (GERD) symptoms (heartburn, regurgitation, acid taste in mouth).
- •Between ages of 18 - 70 inclusive.
- •Develop GERD symptoms following ingestion of a refluxogenic meal.
- •Able to take a stable Proton Pump Inhibitor (PPI) regimen for duration of study.
- •Understand and sign the informed consent form.
排除标准
- •Pregnant or lactating women.
- •Allergic to pumosetrag or formulation excipients.
研究组 & 干预措施
0.2mg Pumosetrag
Experimental
干预措施: Pumosetrag (Drug)
0.5mg Pumosetrag
Experimental
干预措施: Pumosetrag (Drug)
0.8mg Pumosetrag
Experimental
干预措施: Pumosetrag (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
研究者
研究点 (5)
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