NCT01707901已完成1 期
A Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion
研究概览
简要总结
A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal pain hypersensitivity in patients with gastric reflux disease
详细描述
This is a Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
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 (Participant, Investigator)
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
- •Male and female subjects aged 18-70 years inclusive with confirmed GERD and normal oesophageal mucosa will be enrolled in this study. Subjects demonstrate moderate intensity heartburn while being on a stable dose of proton pump inhibitor and demonstrate oesophageal hypersensitivity following distal oesophageal acid perfusion.
排除标准
- •Subjects will be excluded if they have a motility disorder, are not able to tolerate study procedures or have had GI surgery or have a condition that would affect the study results. Subjects with functional heartburn, acute GI symptoms, endoscopic or manometric abnormality or a protocol-specified cardiovascular condition will not be enrolled.
研究组 & 干预措施
ONO-8539
Experimental
ONO-8539
干预措施: ONO-8539 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion
时间窗: 28 Days
Daily, through a pain assessment score chart
次要结局
- To assess the tolerability of ONO-8539(28 Days)
- To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD(28 Days)
- To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation(28 Days)
- To evaluate the effect of ONO-8539 on quality of life(28 Days)
- To investigate the pharmacokinetics of ONO-8539(28 Days)
- To investigate the association among the changes in pharmacodynamics of ONO-8539(28 Days)
- To assess the safety of ONO-8539(28 days)
- To investigate the association among the changes in psychological parameters of ONO-8539(28 days)
- To investigate the association between the changes in pharmacodynamic parameters of ONO-8539 and the plasma concentrations of ONO-8539(28 Days)
- To evaluate the use of antacid in each treatment group(28 Days)
研究者
研究点 (2)
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