NCT00703534已完成2 期
Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period
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
- 478
- 试验地点
- 1
- 主要终点
- Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary
研究概览
简要总结
This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subject able to read and write US english and able to use electronic devices
- •Subjects who have experienced GERD symptoms for at least six months
- •Subjects currently taking a prescription or over-the-counter PPI medications for GERD
- •Body Mass Index (BMI) 18.5-35.0, inclusive
排除标准
- •Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment
- •Subjects who have any of the following conditions or diseases- Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer
- •Prior surgery of the upper Gastrointestinal (GI) tract
研究组 & 干预措施
AZD3355
Experimental
干预措施: AZD3355 (Drug)
AZD3355
Experimental
干预措施: Gelusil® (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Gelusil® (Drug)
结局指标
主要结局
Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary
时间窗: Run-in period of 8-12 days and treatment period of 26-30 days
Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)
次要结局
未报告次要终点
研究者
研究点 (1)
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