NCT01043185已完成2 期
A Double-blind, Placebo Controlled, Randomised, Phase IIA Pharmacodynamic 4-way Cross-over Study to Estimate the Dose Response Relationship of AZD3355 on the Number of Reflux Episodes Assessed by Impedance/pH in Patients With GERD and a Partial Response to PPI Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Total Number of Reflux Episodes During 24 Hours
研究概览
简要总结
The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Provide informed consent
- •History of GERD with persistent symptoms despite treatment with PPI
- •Otherwise normal physical health
排除标准
- •History of GERD with symptoms that has not improved at all during treatment with PPI
- •Prior surgery of the upper gastrointestinal tract
- •History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD
研究组 & 干预措施
A
Experimental
AZD3355 30 mg
干预措施: AZD3355 (Drug)
B
Experimental
AZD3355 90 mg
干预措施: AZD3355 (Drug)
C
Experimental
AZD3355 120 mg
干预措施: AZD3355 (Drug)
D
Experimental
AZD3355 240 mg
干预措施: AZD3355 (Drug)
E
Placebo Comparator
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Total Number of Reflux Episodes During 24 Hours
时间窗: Measured during 24 hours at 4 different visits with a 7-28 days interval between
Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)
次要结局
- Number of Weakly Acidic Reflux Episodes(Measured during 24 hours at 4 different visits with a 7-28 days interval between)
- Number of Weakly Alkaline Reflux Episodes(Measured during 24 hours at 4 different visits with a 7-28 days interval between)
- Number of Acid Reflux Episodes(Measured during 24 hours at 4 different visits with a 7-28 days interval between)
研究者
研究点 (1)
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