Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia
研究概览
简要总结
Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal, hypersensitivity of the afferent nerves of the gut, psychological disturbances and central nervous system dysfunction have been proposed.
Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory. Only small benefits relative to placebo have been found with histamine H2 receptor antagonists, proton pump inhibitor and Helicobacter pylori eradication.
Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent is currently indicated for patients with various upper GI symptoms.
This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking test)and symptoms in FD patients
详细描述
phase3 clinical trial
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III criteria (1) will be considered
- •Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test.
- •duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology
- •A normal upper abdominal ultrasound
- •Willing to participate and give consent for participation in the study.
排除标准
- •Age <18 years
- •Helicobacter Pylori positive on gastric biopsy and / or UBT.
- •Taking other medications that alter gastric motility like macrolide
- •anti-emetics and antibiotics .
- •Pregnant or breast-feeding females.
研究组 & 干预措施
1.Itopride Group
The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks
干预措施: Itopride, (Drug)
2.Control placebo group
The control group will receive placebo tablets for four weeks
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia
时间窗: 18 months
次要结局
- To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia(18 months)