NCT02818309Unknown2 期
Efficacy and Safety of Lesogaberan (AZD3355) in Chinese Patients With Reflux Symptoms Refractory to Proton Pump Inhibitor Therapy: a Randomized Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Treatment response as assessed by the symptom questionnaire RESQ-eD
研究概览
简要总结
Lesogaberan may be used in Chinese GERD patients with partial response to PPI.
详细描述
To test the efficacy and safety of lesogaberan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lesogaberan
Experimental
Lesogaberan
干预措施: Lesogaberan (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment response as assessed by the symptom questionnaire RESQ-eD
时间窗: 3 years
Treatment response, defined as at most three days with heartburn or regurgitation of not more than mild intensity during the last 7 days of treatment based on RESQ-eD
次要结局
- The change from baseline for each separate symptom domain of the RESQ-eD(3 years)
- Patients' consumption of rescue antacid medication over the 4 week treatment period(3 years)
- Number of participants with treatment-related adverse events as assessed by CRF_20150728(3 years)
- Time to treatment response as assessed by the symptom questionnaire RESQ-eD(3 years)
- Time to sustained absence of symptoms as assessed by the symptom questionnaire RESQ-eD(3 years)
- The proportion of symptom-free days as assessed by the symptom questionnaire RESQ-eD(3 years)
- Subgroup analysis of in patients with different reflux profiles categorized by impedance-pH as assessed by the symptom questionnaire RESQ-eD(3 years)
- Patient compliance with treatment determined by counts of returned unused capsules at each visit during the period of randomised treatment(3 years)
研究者
研究点 (1)
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