A Comparative Study of Lansoprazole and Mosapride for Functional Dyspepsia: Focus on Difference Between Epigastric Pain Syndrome and Postprandial Distress Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 329
- 试验地点
- 1
- 主要终点
- Improvement of dyspeptic symptoms as evaluated by validated questionnaire
研究概览
简要总结
Functional dyspepsia is a common symptom complex with significant impact on quality of life. There is no standard treatment for functional dyspepsia but therapeutic efficacy of proton pump inhibitor (PPI) and prokinetic agent have been proved in subsets of patients. This study has two aims:
- first is to compare the therapeutic efficacy of lansoprazole (a PPI) and mosapride (a prokinetic agent) for functional dyspepsia
- second is to investigate whether different subgroups of functional dyspepsia (e.g., epigastric pain syndrome and postprandial distress syndrome) respond differently to PPI and prokinetic agent.
详细描述
Eligible outpatients with presentation of dyspepsia are enrolled if they fulfilled the criteria of ROME III criteria. A trained assistant helps the eligible patients to complete the ROME III standard questionaire, brief symptom rating scale (BSRS), and Maudsley Personality Inventory (MPI). The enrolled patients are then randomized into either lansoprazole or mosapride group for 14-day treatment. Before starting medication, right after completing the medication, and 1 month after the medication, the enrolled patients complete standardized severity questionnaire (Hong-Kong Index) to evaluate severity of dyspeptic symptoms. Symptom improvement is then determined.
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
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged more than 20 years old
- •diagnosis of functional dyspepsia by fulfilling Rome-III criteria
- •outpatient
排除标准
- •aged less than 20 years
- •organic lesions including ulcers, tumors, bleeding, vasculopathy or esophagitis as demonstrated on upper endoscopy
- •concurrent illness with malignancy, diabetes mellitus, liver cirrhosis, renal failure or porphyria
- •diagnosis of organic disease for dyspeptic symptoms by treating physicians
- •history of abdominal surgery
- •concurrent user of aspirin and NSAID
- •history of allergy or severe side effects to lansoprazole or mosapride
- •pregnant or lactating women
研究组 & 干预措施
1
Treatment with lansoprazole (30 mg) once daily for 14 days
干预措施: lansoprazole (Drug)
2
Treatment with mosapride (5 mg) thrice daily for 14 days
干预措施: mosapride (Drug)
结局指标
主要结局
Improvement of dyspeptic symptoms as evaluated by validated questionnaire
时间窗: After 2-week treatment of lansoprazole or mosapride
次要结局
未报告次要终点