Efficacy of Motilitone on Gastric Emptying in Patients With Functional Dyspepsia:
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Evaluation in gastric emptying rate after the test meal
研究概览
简要总结
Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal pain or discomfort in the absence of a specific structural cause.1 Several mechanisms have been suggested to underlie dyspeptic symptoms. In a barostat study by Tack et al.2, impaired gastric accommodation to a meal was found in 40% of patients with FD, and this abnormality was associated with early satiety. Delayed gastric emptying (GE) was also found in almost 40% of patients with FD, and was associated with the symptoms of postprandial fullness, vomiting and early satiety.3-5 Improving gastric accommodation and prokinetic effect seem to be an attractive physiological target in patients with FD. Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was launched in December 2011 in Korea for treating patients with FD. It has multiple mechanisms of action such as fundus relaxation, visceral analgesia and prokinetic effects.6 The current study aims to evaluate effects of motilitone on gastric emptying and accommodation after a meal in patients with FD using three-dimensional gastric volume measurements by magnetic resonance imaging (MRI). Patients are randomly allocated to receive either motilitone 90 mg daily, motilitone 180 mg daily or placebo in a double blinded manner. After 2 weeks of treatment, patients undergo gastric MRI. The primary endpoint is gastric emptying rate. The secondary endpoints are gastric accommodation and symptom improvement.
详细描述
Same as above
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
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 and 70 years of age
- •Diagnosed of functional dyspepsia patients by ROME III diagnostic criteria
- •Symptom scores three-point by 8 kinds of symptoms on NDI-K table
- •Signed written informed consent.
排除标准
- •Any functional GI diease
- •Previous abdominal surgery
- •pregnancy or lactation
- •Other conditions likely to interfere with study procedures. as judged by the investigator
- •Allergic history to motilitone
- •Contraindications to MRI
- •Significant cardiopulmonary disease
- •Significant renal(serum creatinine level≥1.5 x the upper normal limit) or liver (AST or ALT≥2.5xULN)disease
- •Can not be stopped taking medications that gastric motility booster and antacid prior to the start of the study
- •Uncontrollable diabetes mellitus (HbA1C>7%)
- •Any malignancies within 5 years prior to the start of the study
研究组 & 干预措施
motilitone 90mg
Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.
干预措施: motilitone (Drug)
motilitone 180mg
Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.
干预措施: motilitone (Drug)
placebo
Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation in gastric emptying rate after the test meal
时间窗: Evaluation in gastric emptying rate 120min after the test meal
次要结局
- Gastric emptying rate(GE)(GE 15min 30min 60min after the test meal.)
- The secondary endpoints are gastric accommodation and symptom improvement.(This outcome is measured on day 14 after 2 weeks of treatment)
- Change in total gastric volume (TGV) after the test meal(This outcome is measured on day 14 after 2 weeks of treatment.The change is defined as difference between TGV 15min after the test meal and at the pre-test meal.)
- Change in proximal to distal total gastric volume (TGV) ratio afrer the test meal(The change is defined as difference between proximal TGV 15min after the test meal and at the pre test meal)
- Change in proximal total gastric volume (TGV) after the test meal(The chanfe is defined as difference between proximal TGV 15min after the test meal)
研究者
Poong-Lyul Rhee
Clinical Professor
Samsung Medical Center
