To Compare the Efficacy and Safety of Acotiamide Versus Itopride in Patient With Post Prandial Distress Syndrome Type of Functional Dyspepsia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 主要终点
- Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 8 weeks
研究概览
简要总结
The goal of this study is to "To compare the efficacy and safety of Acotiamide versus Itopride in patient with post prandial distress syndrome type of functional dyspepsia"
详细描述
Investigator is aiming to conduct an Open-label, comparative randomized controlled, parallel, two-arms, multi-center study.
Primary Outcomes:
• Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale (LPDS) in 8 weeks from the baseline
Secondary Outcomes:
- Difference between both groups in symptoms of Postprandial Distress Syndrome (PDS) (including early satiety, abdominal bloating, postprandial fullness) by using Leuven Postprandial Distress Scale (LPDS)
- Difference between both groups in quality of life by using short form Nepean Dyspepsia Index (SF-NDI) from baseline
- Frequency of adverse events, serious adverse events and tolerability in both groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects to provide written informed consent prior to any study procedures being performed
- •Subjects with age 18-70 both male and female
- •Diagnosed with FD (PDS) by using ROME IV criteria
- •Subjects naive to acotiamide and Itopride for last 2 weeks
- •Subjects must have a normal endoscopy result within the 6 months
排除标准
- •Without predominant symptoms of ulcer and GERD based on history & endoscopy, IBS based on history & Rome IV criteria and Chronic idiopathic nausea based on history only
- •Subjects taking drugs that affect gut motility, gut sensitivity, SSRI and/or acid secretion who are unable to discontinue these drugs before initiating the intervention
- •Subjects with chronic medical disorders potentially contributing to PDS such as chronic pancreatitis, hypothyroidism, CKD and CLD identified through clinical history, physical examination, or previous medical records
- •Subjects with Type I or Type II diabetes
- •Pregnant & lactating mothers
研究组 & 干预措施
assignment of participants to treatment group A (Acotiamide)
干预措施: Acotiamide (Drug)
assignment of participants to treatment group B (Itopride).
干预措施: Acotiamide (Drug)
结局指标
主要结局
Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 8 weeks
时间窗: 8 weeks
Overall treatment effect will be assessed using the Leeds Postprandial Distress Scale, with change in total score from baseline before initiation of treatment end of treatment. The decreased score representing the treatment response.
次要结局
- Difference between both groups in symptoms of Postprandial Distress Syndrome (PDS) (including early satiety, abdominal bloating, postprandial fullness) by using Leuven Postprandial Distress Scale(8 weeks)
- Difference between both groups in quality of life by using short form Nepean Dyspepsia Index scale(8 weeks)
- Frequency of adverse events, serious adverse events and tolerability in both groups(8 weeks)